Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
National Healthcare Mfg. Corp. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
88 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972013 | NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PA | National Healthcare Mfg. Corp. | 1997-08-26 | 88 | 0 |
| K971465 | NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS | National Healthcare Mfg. Corp. | 1997-06-04 | 43 | 0 |
| K971317 | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | National Healthcare Mfg. Corp. | 1997-05-08 | 29 | 0 |
| K962670 | NHMC IRRIGATION TRAY | National Healthcare Mfg. Corp. | 1996-08-14 | 36 | 0 |
| K962254 | NHMC URETHRAL CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-07-29 | 47 | 0 |
| K960523 | NHMC DRESSING TRAY | National Healthcare Mfg. Corp. | 1996-04-04 | 58 | 0 |
| K960566 | NHMC FOLEY CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-02-29 | 20 | 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