Arnold-King Pressure Dressing
FDA 510(k) K864688 · Angiosystems, Inc.
510(k) numberK864688
Submission
- Device name
- Arnold-King Pressure Dressing
- Applicant
- Angiosystems, Inc.
Stone Mountain, GA, US - Received
- December 2, 1986
- Decision date
- January 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NAD – Dressing, Wound, Occlusive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4020
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254246 | LT Antibacterial Foam with Silver DressingNAD · Traditional | Zhejiang Longterm Medical Technology Co., Ltd. | 09/10/2026SE |
| K102403 | Sam Chest Seal with Vavle; Sam Chest SealNAD · Traditional | Sam Medical Products | 03/03/2011SE |
| K091133 | Aplion Topical Care SystemNAD · Traditional | Aplion Medical,Llc | 05/20/2009SE |
| K072560 | Envela (Hydrohesive Occlusive Dressing)NAD · Traditional | Teikoku Pharma USA, Inc. | 06/17/2008SE |
| K080524 | Centurion Sorbaview OTCNAD · Traditional | Tri-State Hospital Supply Corp. | 04/23/2008SE |
| K060046 | DermastreamNAD · Traditional | Enzysurge , Ltd. | 02/27/2006SE |
| K043063 | Oxyband Wound DressingNAD · Traditional | Oxyband Technologies, Inc. | 03/24/2005SE |
| K020781 | Wet ChamberNAD · Traditional | Kinetic Concepts, Inc. | 05/06/2002SE |
| K990530 | Kerlix MD Antimicrobial Gauze DressingNAD · Traditional | The Kendall Company, L.P. | 01/31/2000SE |
| K990861 | Wound Dressing/Abd Pad, Model #10810NAD · Traditional | Hospital Specialty Co. | 04/12/1999SE |
More from Hospital Specialty Co.
| 510(k) | Device | Decision |
|---|---|---|
| K905464 | Medical Procedure Kits/Arterial Blood SamplingCBT · Traditional | 05/31/1991SEKD |
| K905459 | Surgical Procedure Tray/Laparoscopy CholecystectomLRO · Traditional | 04/05/1991SE |
| K905461 | Procedure Kit/Routine Dental ProceduresEKS · Traditional | 03/05/1991SEKD |
| K905466 | Sterile Disposable Surgical Drape/Abdominal DrapeKKX · Traditional | 02/11/1991SE |
| K905465 | Sterile Dispos Surgical Drape/C-Section DrapeKKX · Traditional | 02/11/1991SE |
| K905462 | Procedure Tray/For Various Ophthalmic ProceduresLRP · Traditional | 02/06/1991SE |
| K905460 | Sterile Disposable Drape/Ophthalmic SurgeryHMT · Traditional | 02/06/1991SE |
| K905463 | General Medical Procedure Kit/Skin PreparationFOZ · Traditional | 01/22/1991SEKD |
| K843260 | Angiosys Femoral Angiography DrapeKKX · Traditional | 09/21/1984SE |
| K843259 | Angio Sys Fluoroscope Drape · Traditional | 09/21/1984SE |
Questions and answers
When was Arnold-King Pressure Dressing cleared by the FDA?
Arnold-King Pressure Dressing (K864688) received a 510(k) decision of Substantially Equivalent on January 12, 1987, 41 days after the submission was received.
What is the product code of K864688?
The FDA product code is NAD – Dressing, Wound, Occlusive, a Class I (low risk) device regulated under 21 CFR 878.4020.