Product code KDQ
- Device name
- Bottle, Collection, Vacuum
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6740
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K081718 | EXPRESS CHEST DRAIN | Atrium Medical Corp. | 2008-07-25 |
| K062302 | MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM | Millicore AB | 2006-10-06 |
| K043582 | OCEAN CHEST DRAIN | Atrium Medical Corp. | 2005-01-21 |
| K984496 | ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN | Atrium Medical Corp. | 1999-05-05 |
| K962856 | PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR | Deknatel, Inc. | 1996-08-28 |
| K961287 | ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM | Rocket Medical Plc | 1996-07-26 |
| K962168 | MUCUS SPECIMEN TRAP | Sage Products, Inc. | 1996-07-22 |
| K950677 | ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN | Atrium Medical Corp. | 1995-04-13 |
| K941818 | PM9000 VAC TRAP | Precision Medical, Inc. | 1994-12-12 |
| K932327 | THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM | Davol, Inc. | 1993-07-13 |
| K912704 | ATRIUM 2000 CHEST DRAIN | Atrium Medical Corp. | 1991-08-26 |
| K905768 | PLEUR-EVAC CHEST DRAINAGE SYSTEMS | Deknatel, Inc. | 1991-02-11 |
| K897125 | ATRIUM 2000, CHEST DRAIN | Atrium Medical Corp. | 1990-03-30 |
| K896697 | PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI | Deknatel, Inc. | 1990-02-08 |
| K896127 | THORA-KLEX CHEST DRAINAGE UNIT | Davol, Inc. | 1990-01-24 |
| K892915 | PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION | Deknatel, Inc. | 1989-06-21 |
| K882468 | ELIMINATOR AIR FILTER | Apex Medical, Inc. | 1988-08-29 |
| K882223 | PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST | Deknatel, Inc. | 1988-08-16 |
| K881149 | MUCUS TRAP OR SUCTION TRAP | Ferguson Medical | 1988-06-14 |
| K863561 | URESIL THORACIC VENT | Uresil Corp. | 1986-09-23 |
| K861025 | T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES | Boehringer Laboratories | 1986-04-28 |
| K855074 | FILTERED VACUUM SAFETY TRAP BOTTLE | Boehringer Laboratories | 1986-03-13 |
| K854359 | LM2000A SURGICAL SUCTION MONITOR | Engineering, Inc. | 1986-03-03 |
| K860023 | COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT | Atrium Medical Corp. | 1986-01-10 |
| K854634 | BARD PARKER THORACIC VENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-12-27 |
| K844853 | NIFA NON INVASIVE FLUTTER ASSEMBLY | Emergency Management Products, Inc. | 1985-12-12 |
| K851244 | GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO | Cook, Inc. | 1985-11-19 |
| K851892 | COMPACT 2000 | Atrium Medical Corp. | 1985-06-14 |
| K851316 | ABCO SUCTION CANISTER | Abco Dealers, Inc. | 1985-05-08 |
| K844942 | PLURA-GARD CHEST DRAINAGE SYSTEM | Consolidated Medical Equipment, Inc. | 1985-03-12 |
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| 10192253002645 | Thora-Seal | Cardinal Health 200, LLC | 2025-02-18 |
| 10073088165302 | BEMIS | BEMIS MANUFACTURING COMPANY | 2025-02-07 |
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| 10073088162653 | BEMIS | BEMIS MANUFACTURING COMPANY | 2024-10-15 |
| 10195327424237 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2023-07-29 |
| 10195594767143 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-08-10 |
| 10195327199968 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-07-17 |
| 10195594742126 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-07-15 |
| 07612367078139 | Thopaz Tubing Extension, 3 Lines, sterile | Medela AG | 2021-06-22 |
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| 10612479243139 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-06-24 |
| 10612479243153 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2019-06-24 |
| 07613252027249 | NA | STRYKER CORPORATION | 2017-11-15 |
| 10351688408723 | Portex | ICU MEDICAL, INC. | 2016-12-28 |
| 10351688429735 | Portex | ICU MEDICAL, INC. | 2016-12-28 |
| 07613327055290 | Fluid Safe | STRYKER CORPORATION | 2016-09-23 |
| H862TVST0 | Thora-Vent Thoracic Vent | URESIL, LLC | 2016-09-07 |
| H862TVOCP0 | Thora-Vent Thoracic Vent | URESIL, LLC | 2016-09-07 |
| H862TV13130 | Thora-Vent Thoracic Vent | URESIL, LLC | 2016-09-07 |
| H862TV13100 | Thora-Vent Thoracic Vent | URESIL, LLC | 2016-09-07 |
| H862TV11130 | Thora-Vent Thoracic Vent | URESIL, LLC | 2016-09-07 |
| H862TV11100 | Thora-Vent Thoracic Vent | URESIL, LLC | 2016-09-07 |
| H862OTW11130 | Thora-Vent Thoracic Vent | URESIL, LLC | 2016-09-07 |