Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
272 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202843 | Surgical Face Masks (Sterile), Surgical Face Masks (Non-ster | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2021-01-12 | 109 | 0 |
| K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2020-12-31 | 106 | 0 |
| K152618 | PANTHER Cutter Stapler | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2015-11-12 | 59 | 0 |
| K142577 | PANTHER Endo Linear Cutter Staplers with Single Use Loading | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2015-06-11 | 272 | 0 |
| K103470 | PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. | 2011-01-11 | 46 | 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