Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MIA — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
925 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172800 | Portex® Lancet Point Spinal Needles with NRFit™ connectors, | Smiths Medical Asd, Inc. | 2018-06-14 | 269 | 0 |
| K051860 | FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837 | Epimed International, Inc. | 2005-08-22 | 45 | 0 |
| K983858 | SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES | Sims Portex, Inc. | 1999-01-29 | 88 | 0 |
| K982269 | CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, | Allegiance Healthcare Corp. | 1998-07-23 | 24 | 0 |
| K971645 | REGANES SPINAL NEEDLE (VARIOUS) | Avid N.I.T., Inc. | 1997-08-01 | 88 | 0 |
| K970997 | NEO-CARE LUMBER PUNCTURE KIT | Klein-Baker Medical, Inc. | 1997-05-22 | 64 | 0 |
| K961324 | GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), | Global Medical Prods, Inc. | 1996-07-02 | 85 | 0 |
| K960405 | SPINAL NEEDLE | Promex, Inc. | 1996-02-28 | 30 | 0 |
| K942442 | ACUFEX T-FIX DELIVERY SYSTEM | Acufex Microsurgical, Inc. | 1994-12-05 | 196 | 0 |
| K904380 | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM | Custom Medical Concepts, Inc. | 1993-04-08 | 925 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda