Qualtex Needle Counters
510(k) K903947
Qualtex Needle Counters is a Class II device made by Deroyal Industries, Inc., cleared under FDA 510(k) K903947 on 30 Oct 1990, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903947 | Date30 Oct 1990 | StatusActive |
Official records
- FDA 510(k) database K903947
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MMK
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MMK (Container, Sharps).
- DISPOSABLE NEEDLE COUNTER by Anago, Inc.
- PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) by PUREWAY COMPLIANCE, INC.
- SHARPSCAN by Medical Engineering Development Solutions, Inc.
- IN-ROOM AND SHARPSTAR by SAGE PRODUCTS LLC
- CHEMOTHERAPY WASTE DISPOSAL CONTAINERS by SAGE PRODUCTS LLC
- Tiger Sharps Containers by International Marketing Specialists, Inc.
- Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 by Ningbo Maxcon Medical Technology Co., Ltd.
- PureWay 1.4 Quart Sharps Collector by PUREWAY COMPLIANCE, INC.
- Enviro Sharp Solutions 3 by Industrial Water Solutions, Inc.
- Red2Green Reusable Sharps Container by Triumvirate Environmental, Inc.