Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicare Industries, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
12 daysmedian FDA review time
70 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K894197 | LATEX EXAMINATION GLOVES | Medicare Industries, Inc. | 1989-08-24 | 70 | 0 |
| K891865 | NIL (PATIENT EXAMINATION GLOVES - LATEX) | Medicare Industries, Inc. | 1989-05-25 | 59 | 0 |
| K791434 | SPONGE COUNTER BAGS | Medicare Industries, Inc. | 1979-10-09 | 70 | 0 |
| K781980 | RESPIRATORY THERAPY GAS POUCH | Medicare Industries, Inc. | 1978-12-07 | 10 | 0 |
| K781981 | DECONTAMINATION ITEMS BAG | Medicare Industries, Inc. | 1978-12-07 | 10 | 0 |
| K781925 | POUCHES, GAS STERILIZATION | Medicare Industries, Inc. | 1978-11-22 | 12 | 0 |
| K781924 | POUCHES AND TUBING, MEDI-SEAL | Medicare Industries, Inc. | 1978-11-22 | 12 | 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