Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgiquest, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
159 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015-03-20 | 112 | 11 |
| K132169 | SURGIQUEST AIRSEAL IFS | Surgiquest, Inc. | 2013-08-22 | 38 | 0 |
| K121336 | MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM | Surgiquest, Inc. | 2012-07-03 | 61 | 0 |
| K103692 | SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGR | Surgiquest, Inc. | 2011-05-25 | 159 | 0 |
| K100180 | SURGIQUEST ANCHORPORT SIL KIT | Surgiquest, Inc. | 2010-05-05 | 104 | 0 |
| K092504 | SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM | Surgiquest, Inc. | 2009-11-05 | 83 | 0 |
| K083211 | AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM | Surgiquest, Inc. | 2008-12-15 | 45 | 0 |
| K071571 | SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM | Surgiquest, Inc. | 2007-07-30 | 52 | 0 |
| K063859 | SURGIQUEST ELASTOMERIC OPTICAL TROCAR & CANNULA | Surgiquest, Inc. | 2007-03-14 | 76 | 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