MIA
10 FDA 510(k) clearances · Product code
88 daysmedian time to decision
925 days90th percentile
10clearances measured
FDA profile
- Official device name
- Needle, Spinal, Short Term
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5150
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2015: 12 · 2016: 23 · 2017: 15 · 2018: 14 · 2022: 19 · 2024: 23
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 |
|---|---|---|
| Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors (K172800) | Smiths Medical Asd, Inc. | 2018-06-14 |
| FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 (K051860) | Epimed International, Inc. | 2005-08-22 |
| SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES (K983858) | Sims Portex, Inc. | 1999-01-29 |
| CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GA (K982269) | Allegiance Healthcare Corp. | 1998-07-23 |
| REGANES SPINAL NEEDLE (VARIOUS) (K971645) | Avid N.I.T., Inc. | 1997-08-01 |
| NEO-CARE LUMBER PUNCTURE KIT (K970997) | Klein-Baker Medical, Inc. | 1997-05-22 |
| GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEEDLES (K961324) | Global Medical Prods, Inc. | 1996-07-02 |
| SPINAL NEEDLE (K960405) | Promex, Inc. | 1996-02-28 |
| ACUFEX T-FIX DELIVERY SYSTEM (K942442) | Acufex Microsurgical, Inc. | 1994-12-05 |
| SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM (K904380) | Custom Medical Concepts, Inc. | 1993-04-08 |
Track MIA automatically
Every clearance here is in the API, with alerts when new ones post.