Aqua-Seal
FDA 510(k) K761202 · Respiratory Care, Inc.
510(k) numberK761202
Submission
- Device name
- Aqua-Seal
- Applicant
- Respiratory Care, Inc.
Mchenry, IL, US - Received
- December 7, 1976
- Decision date
- December 9, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
Other 510(k)s with product code KDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081718 | Express Chest DrainKDQ · Special | Atrium Medical Corp. | 07/25/2008SE |
| K062302 | Millicore AB Digivent Chest Drainage SystemKDQ · Traditional | Millicore AB | 10/06/2006SE |
| K043582 | Ocean Chest DrainKDQ · Special | Atrium Medical Corp. | 01/21/2005SE |
| K984496 | Atrium Medical Corporation Express Chest DrainKDQ · Traditional | Atrium Medical Corp. | 05/05/1999SE |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional | Deknatel, Inc. | 08/28/1996SE |
| K961287 | Rocket Pleuraseal II Chest Drainage SystemKDQ · Traditional | Rocket Medical Plc | 07/26/1996SE |
| K962168 | Mucus Specimen TrapKDQ · Traditional | Sage Products, Inc. | 07/22/1996SE |
| K950677 | Atrium Dry Suction Control Water Seal Chest DrainKDQ · Traditional | Atrium Medical Corp. | 04/13/1995SE |
| K941818 | PM9000 Vac TrapKDQ · Traditional | Precision Medical, Inc. | 12/12/1994SE |
| K932327 | Thora-Klex 350 ML Pediatric Chest Drainage SystemKDQ · Traditional | Davol, Inc. | 07/13/1993SE |
More from Davol, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K892230 | Rci Viral/Bacterial FilterCAH · Traditional | 08/28/1989SE |
| K884150 | Modified Conchatherm III Controlled HeaterBTT · Traditional | 11/21/1988SE |
| K881625 | Conchatherm III Plus Dual Heat Wire Servo ControllBZE · Traditional | 06/21/1988SE |
| K864147 | AquavalveBYH · Traditional | 12/05/1986SE |
| K863955 | Colby Level AlarmBTT · Traditional | 11/07/1986SE |
| K861555 | Circapak Universal Volume Ventilator CircuitBZD · Traditional | 06/05/1986SE |
| K834151 | Conchatherm LHF Humidifier HeaterBTT · Traditional | 01/13/1984SE |
| K833974 | Aquapak 020 Humidifier AdapterBTT · Traditional | 12/16/1983SE |
| K832453 | Slimb Single Limb Breathing CircuitCAI · Traditional | 10/27/1983SE |
| K811524 | AquacadeLHC · Traditional | 07/01/1981SE |
Questions and answers
When was Aqua-Seal cleared by the FDA?
Aqua-Seal (K761202) received a 510(k) decision of Substantially Equivalent on December 9, 1976, 2 days after the submission was received.
What is the product code of K761202?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.