Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgi-Quip Inc.U · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
78 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841115 | CHARLES/MCINTYRE GIANT BREAK TABLE | Surgi-Quip Inc.U | 1984-05-09 | 55 | 0 |
| K841116 | MOBILE OPHTHALMIC OPERATING TABLE | Surgi-Quip Inc.U | 1984-05-09 | 55 | 0 |
| K840004 | WEE BAG O'MERCURY | Surgi-Quip Inc.U | 1984-03-22 | 78 | 0 |
| K832887 | ELECTRONIC UNIT | Surgi-Quip Inc.U | 1983-10-04 | 39 | 0 |
| K822427 | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | Surgi-Quip Inc.U | 1982-09-14 | 33 | 0 |
| K822554 | CEMENT EXTRACTION INSTRUMENTATION | Surgi-Quip Inc.U | 1982-09-14 | 21 | 0 |
| K822426 | MCINTYRE MICROSCOPE STAND | Surgi-Quip Inc.U | 1982-09-02 | 21 | 0 |
| K822428 | SURGI-QUIP MICROSCOPE STAND | Surgi-Quip Inc.U | 1982-09-02 | 21 | 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