Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
N-S Medical Products · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
231 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880288 | TRU-TRAC TORQUE GUIDEWIRE | N-S Medical Products | 1988-09-12 | 231 | 0 |
| K880287 | TRU-TRAC COILED GUIDEWIRE | N-S Medical Products | 1988-09-12 | 231 | 0 |
| K881957 | HAWKINS-AKINS BLUNT NEEDLE ACCESS KIT | N-S Medical Products | 1988-05-20 | 10 | 1 |
| K881956 | NATIONAL-STANDARD NEEDLE HOLDER | N-S Medical Products | 1988-05-20 | 10 | 0 |
| K870523 | HAWKINS BREAST LOCALIZATION NEEDLE | N-S Medical Products | 1987-03-09 | 31 | 1 |
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