Product code KME
- Device name
- Bedding, Disposable, Medical
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6060
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042145 | READY-HEAT BLANKET | Techtrade, LLC | 2004-09-17 |
| K944953 | OREX MEDICAL BEDDING | Thantex Specialties, Inc. | 1994-12-02 |
| K933636 | DISPOSE-A-SHEET | Belmac Healthcare Corp. | 1994-01-26 |
| K932539 | DOCTOR DOWN --RESCUE WRAP | Three Dog Down | 1993-11-02 |
| K922143 | AMERICAN BURN SHEET | American Silk Sutures, Inc. | 1992-08-10 |
| K915303 | FOIL BABY BUNTING | Gam Industries, Inc. | 1992-02-20 |
| K912257 | CHEM-SLEEVE B | Haz-Med, Inc. | 1991-12-31 |
| K911953 | MEDI GUARD SHEETS/UNDERLAYS | Sancella, Inc. | 1991-05-28 |
| K911952 | MEDI GUARD UNDERPAD | Sancella, Inc. | 1991-05-28 |
| K911948 | MEDI GUARD PILLOWCASE | Sancella, Inc. | 1991-05-28 |
| K911950 | MEDI GUARD DRAPES | Sancella, Inc. | 1991-05-21 |
| K905003 | BIO-GUARD SHAVE PREP TRAY | Network Medical Systems, Inc. | 1990-12-28 |
| K904274 | RECEIVING BLANKET | Anago, Inc. | 1990-10-26 |
| K901509 | TRAUMA SLEEVE | Haz-Med, Inc. | 1990-09-12 |
| K901629 | CHEM-SLEEVE | Haz-Med, Inc. | 1990-04-27 |
| K900643 | FLUID SOAKERSHIELD | Infection Control Products, Inc. | 1990-04-25 |
| K896043 | MATTRESS COVER FOR MEDICAL PURPOSES | Keystone Veterinary Supplies, Inc. | 1990-01-10 |
| K891986 | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE | Mark One Healthcare Products | 1989-12-29 |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Devon Industries, Inc. | 1989-09-07 |
| K884380 | BED SHEET, PILLOW CASE | Saybrex Intl., Inc. | 1988-11-08 |
| K882332 | HEADREST, PATIENT COMFORT | Surgic Aid, Inc. | 1988-07-19 |
| K881969 | DRY COMFORT DISPOSABLE UNDERPAD | Health Tec, Inc. | 1988-06-07 |
| K881859 | DRIPRIDE DISPOSABLE UNDERPAD | Weyerhaeuser Co. | 1988-06-03 |
| K871725 | DRIPRIDE DISPOSABLE UNDERPADS | Weyerhaeuser Co. | 1987-05-15 |
| K870925 | PAD, BED LINEN PROTECTIVE | Quality Disposables, Inc. | 1987-03-17 |
| K870522 | DEPEND UNDERPAD | Kimberly-Clark Corp. | 1987-03-13 |
| K864158 | THERMAPAD | Avail-Southwest Division | 1987-03-02 |
| K863179 | KIMLON DISPOSABLE BLANKET | Kimberly-Clark Corp. | 1986-08-27 |
| K862348 | SINGLE-USE PATIENT UNDERPAD | Procter & Gamble Mfg. Co. | 1986-07-02 |
| K860066 | REFLECTIVE BLANKET | O.R. Concepts, Inc. | 1986-02-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840117349568 | Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm) | Dynarex Corporation | 2026-06-08 |
| 00840117349544 | Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm) | Dynarex Corporation | 2026-06-08 |
| 16931918119823 | Alleset | GRI Medical & Electronic Technology Co., Ltd. | 2026-06-04 |
| 00199536911109 | Blueline | Transparent Supply Solutions Ltd. | 2026-05-15 |
| 00199536911116 | Blueline | Transparent Supply Solutions Ltd. | 2026-05-15 |
| 00199536911123 | Blueline | Transparent Supply Solutions Ltd. | 2026-05-15 |
| 00199536911130 | Blueline | Transparent Supply Solutions Ltd. | 2026-05-15 |
| 00199536911147 | Blueline | Transparent Supply Solutions Ltd. | 2026-05-15 |
| 00199536911154 | Blueline | Transparent Supply Solutions Ltd. | 2026-05-15 |
| 00199536911161 | Blueline | Transparent Supply Solutions Ltd. | 2026-05-15 |
| 07613327632842 | Sage Multi-Position MATS 2.0 | SAGE PRODUCTS, LLC | 2025-11-19 |
| 07613327632835 | Sage Multi-Position MATS | SAGE PRODUCTS, LLC | 2024-08-12 |
| 00810075281316 | BoneFoam | BONE FOAM, INC. | 2022-12-19 |
| 00810075280081 | BoneFoam | BONE FOAM, INC. | 2022-05-22 |
| 00810075280005 | BoneFoam | BONE FOAM, INC. | 2022-05-22 |
| 00810075280067 | BoneFoam | BONE FOAM, INC. | 2022-05-22 |
| 00810075280074 | BoneFoam | BONE FOAM, INC. | 2022-05-22 |
| 00616784812137 | Drape Sheets, Tissue 2-ply, White, 40" x 48" | Dynarex Corporation | 2021-09-01 |
| 00616784812236 | Drape Sheets | Dynarex Corporation | 2021-09-01 |
| 00616784812335 | Drape Sheets | Dynarex Corporation | 2021-09-01 |
| 00616784813134 | Drape Sheets, Tissue 2-ply, White, 40" x 60" | Dynarex Corporation | 2021-09-01 |
| 00616784813233 | Drape Sheets | Dynarex Corporation | 2021-09-01 |
| 00616784813332 | Drape Sheets | Dynarex Corporation | 2021-09-01 |
| 00616784814131 | Drape Sheets, Tissue 2-ply, White | Dynarex Corporation | 2021-09-01 |
| 00616784815039 | Drape Sheets, Tissue 2-ply, Blue, 40" x 90" | Dynarex Corporation | 2021-09-01 |
| 00616784815138 | Drape Sheets, Tissue 2-Ply, white, 40" x 90" | Dynarex Corporation | 2021-09-01 |
| 00616784816135 | Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White | Dynarex Corporation | 2021-09-01 |
| 00616784810133 | Exam Gowns, Tissue/Poly/Tissue 3-ply, White, Universal | Dynarex Corporation | 2021-04-22 |
| 00616784810232 | Exam Gowns, Tissue/Poly/Tissue 3-ply, Blue, Universal | Dynarex Corporation | 2021-04-22 |
| 00616784810331 | Exam Gowns, Tissue/Poly/Tissue 3-ply, Mauve, Universal | Dynarex Corporation | 2021-04-22 |