Eliminator Air Filter
FDA 510(k) K882468 · Apex Medical, Inc.
510(k) numberK882468
Submission
- Device name
- Eliminator Air Filter
- Applicant
- Apex Medical, Inc.
Martinsville, IN, US - Received
- June 15, 1988
- Decision date
- August 29, 1988
- 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 |
|---|---|---|
| K213577 | VenAir, Sequential Compression SystemJOW · Traditional | 06/28/2022SE |
| K193206 | WiZARD 510 Nasal MaskBZD · Traditional | 10/29/2020SE |
| K182394 | WiZARD 310/320 Series CPAP MaskBZD · Traditional | 05/17/2019SE |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX SeriesBZD · Traditional | 09/15/2015SE |
| K141522 | Apex Medical Corp. Ich CPAP with Pva 9S-007XXX SeriesBZD · Traditional | 10/06/2014SE |
| K121642 | Wizard 230 Nasal Pilow MaskBZD · Traditional | 06/06/2013SE |
| K112079 | Apex Medical XT Auto CPAP with Compliance Improvement Algorithm 9S-005720BZD · Traditional | 12/06/2012SE |
| K120035 | Apex Medical Ich CPAP Series (9S-007XXX)BZD · Special | 05/16/2012SE |
| K103174 | Apex Medical Wizard Series CPAP MaskBZD · Traditional | 05/06/2011SE |
| K103535 | Vacplus Suction UnitJCX · Traditional | 02/24/2011SE |
Questions and answers
When was Eliminator Air Filter cleared by the FDA?
Eliminator Air Filter (K882468) received a 510(k) decision of Substantially Equivalent on August 29, 1988, 75 days after the submission was received.
What is the product code of K882468?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.