Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Unimicro Medical Systems (Shenzhen) Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
199 daysmedian FDA review time
423 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141594 | Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Tro | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015-08-10 | 423 | 0 |
| K150068 | Unimicro Veress Needle | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015-07-31 | 199 | 0 |
| K142208 | Monopolar Laparascopic Accessories | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2015-04-13 | 245 | 0 |
| K141593 | UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2014-11-13 | 153 | 0 |
| K141592 | UNIMICRO SUCTION IRRIATION TUBING SET | Unimicro Medical Systems (Shenzhen) Co., Ltd. | 2014-08-04 | 52 | 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