Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMJ · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
73 daysmedian FDA review time
175 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170305 | Spinal Manometer NRFit; Spinal Manometer LUER | PAJUNK GmbH Medizintechnologie | 2017-07-25 | 175 | 0 |
| K032432 | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER | Busse Hospital Disposables, Inc. | 2003-08-28 | 22 | 0 |
| K970287 | LUMBAR PUNCTURE KIT | B.Braun Medical, Inc. | 1997-04-07 | 73 | 0 |
| K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807 | Smiths Industries Medical Systems, Inc. | 1996-10-18 | 43 | 0 |
| K910089 | MEGA LUMBAR PUNCTURE KIT | Megadyne Medical Products, Inc. | 1991-06-20 | 162 | 0 |
| K882405 | HYPODERMIC NEEDLE SHEATH HOLDER | Ansr Ent., Inc. | 1988-06-29 | 19 | 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