510(k) K190005
- Device
- Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
- Applicant
- Sterilucent, Inc.
- 510(k) number
- K190005
- Product code
- MLR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-09-13
- Date received
- 2019-01-02
- Regulation
- 880.6860
- Classification name
- Sterilizer, Chemical
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Peter Kalkbrenner
- Address
- 1400 Marshall St., NE Minneapolis MN US 55413 55413
FDA Registration Numbers#
- 3005899764
- 3000268902
- 3015207155
- 3030733800
- 3012892649
- 3005646850
- 3014848734
- 3014272734
- 3015392401
- 3001124136
- 3043237009
- 3003950207
- 3013934196
- 3013176080
- 1527821
- 2084725
- 3016075971
- 3035366890
- 3012494290
- 1822565
- 9680353
- 3013557562
- 3014302784
Source Documents#
Other 510(k) Records For Product Code MLR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | 2026-04-15 |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) | Advanced Sterilization Products, Inc. | 2025-04-14 |
| K231893 | LOWTEM Crystal 120 | Lowtem Co., Ltd. | 2024-09-18 |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077) | Advanced Sterilization Products | 2024-07-05 |
| K233762 | SteroScope® Sterilization Technology System | Ideate Medical, Inc. | 2024-06-27 |
| K233065 | V-PRO maX 2 Low Temperature Sterilization System | Steris | 2023-10-20 |
| K223476 | V-PRO maX 2 Low Temperature Sterilization System | STERIS Corporation | 2023-08-07 |
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | 2023-05-25 |
| K223015 | STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette | Plasmapp Co,., Ltd. | 2023-05-09 |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. | 2023-04-14 |
| K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System | Steris | 2022-09-09 |
| K220404 | STERRAD NX with ALLClear Technology | Advanced Sterilization Products, Inc. | 2022-05-16 |
| K212200 | STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette | Plasmapp Co,., Ltd. | 2021-10-22 |
| K212174 | STERRAD 100NX Sterilizer with ALLClear Technology | Advanced Sterilization Products, Inc. | 2021-10-09 |
| K190917 | V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems | STERIS Corporation | 2019-05-09 |
Legacy Summary#
summary
FDA Review#
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