FMJ
6 FDA 510(k) clearances · Product code
73 daysmedian time to decision
175 days90th percentile
6clearances measured
FDA profile
- Official device name
- Manometer, Spinal-Fluid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2500
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2002: 2 · 2010: 7 · 2012: 28 · 2013: 101 · 2014: 176 · 2015: 84
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Spinal Manometer NRFit; Spinal Manometer LUER (K170305) | PAJUNK GmbH Medizintechnologie | 2017-07-25 |
| BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER (K032432) | Busse Hospital Disposables, Inc. | 2003-08-28 |
| LUMBAR PUNCTURE KIT (K970287) | B.Braun Medical, Inc. | 1997-04-07 |
| SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) (K963570) | Smiths Industries Medical Systems, Inc. | 1996-10-18 |
| MEGA LUMBAR PUNCTURE KIT (K910089) | Megadyne Medical Products, Inc. | 1991-06-20 |
| HYPODERMIC NEEDLE SHEATH HOLDER (K882405) | Ansr Ent., Inc. | 1988-06-29 |
Track FMJ automatically
Every clearance here is in the API, with alerts when new ones post.