Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kentec Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
192 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K120272 | AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET | Kentec Medical, Inc. | 2012-02-17 | 18 | 0 |
| K100526 | AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE | Kentec Medical, Inc. | 2010-04-22 | 57 | 2 |
| K050443 | ACCU-LEAD | Kentec Medical, Inc. | 2005-09-02 | 192 | 0 |
| K970686 | ACCUTEMP-PROBE | Kentec Medical, Inc. | 1997-08-25 | 181 | 0 |
| K960080 | ACCUTEMP PROBE | Kentec Medical, Inc. | 1996-05-01 | 111 | 0 |
| K853475 | GRAM-MA NEONATAL SC | Kentec Medical, Inc. | 1985-09-05 | 16 | 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