Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Asia-Med GmbH and CO KG · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132896 | CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HAND | Asia-Med GmbH and CO KG | 2013-12-02 | 77 | 0 |
| K052085 | STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TY | Asia-Med GmbH and CO KG | 2005-10-14 | 73 | 0 |
| K031716 | SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE | Asia-Med GmbH and CO KG | 2003-07-10 | 37 | 0 |
| K011808 | ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, A | Asia-Med GmbH and CO KG | 2001-07-10 | 29 | 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