Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Oriental Medical Supplies, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
116 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K893372 | LATEX EXAMINATION GLOVES | Oriental Medical Supplies, Inc. | 1989-08-21 | 116 | 0 |
| K871666 | MODEL HP (OR MODEL 1001) TRANSCUTANEOUS STIMULATOR | Oriental Medical Supplies, Inc. | 1987-06-25 | 58 | 0 |
| K853442 | MODEL 804 (TENS) | Oriental Medical Supplies, Inc. | 1985-12-09 | 115 | 0 |
| K853416 | MES-TENS(TENS) | Oriental Medical Supplies, Inc. | 1985-11-07 | 85 | 0 |
| K852610 | HOT PACK | Oriental Medical Supplies, Inc. | 1985-08-12 | 54 | 0 |
| K850566 | MARUKYR-BAN / HOT OR HEAT PACK | Oriental Medical Supplies, Inc. | 1985-05-29 | 106 | 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