Thora-Klex Chest Drainage Unit
FDA 510(k) K896127 · Davol, Inc.
510(k) numberK896127
Submission
- Device name
- Thora-Klex Chest Drainage Unit
- Applicant
- Davol, Inc.
Cranston, RI, US - Received
- October 23, 1989
- Decision date
- January 24, 1990
- 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 |
|---|---|---|
| K251557 | Bard® Mesh; Bard® Mesh Pre-ShapedFTL · Special | 06/12/2025SE |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-ShapedFTL · Traditional | 04/09/2025SE |
| K031213 | Aquasens Fluid Monitoring SystemHIG · Traditional | 04/30/2003SE |
| K030307 | Davol Arthrovent Outflow TubingHRX · Traditional | 02/13/2003SE |
| K003323 | Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205FTL · Traditional | 01/22/2001SE |
| K003790 | Davol X-Stream Laparoscopic Irrigation System, Models 5551000, 5552000, 5552001, 552002…GCJ · Traditional | 12/22/2000SE |
| K931899 | Davol AtsCAC · Traditional | 11/15/1994SE |
| K941334 | Davol Laparoscopic Suction Irrigation ProbeHET · Traditional | 06/14/1994SE |
| K921405 | Davol Suction/Irrigator W/ Interchangeable TipHFG · Traditional | 03/25/1994SE |
| K935503 | Davol Laparoscopic Insufflation Tubing SetHIF · Traditional | 03/07/1994SE |
Questions and answers
When was Thora-Klex Chest Drainage Unit cleared by the FDA?
Thora-Klex Chest Drainage Unit (K896127) received a 510(k) decision of Substantially Equivalent on January 24, 1990, 93 days after the submission was received.
What is the product code of K896127?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.