Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Frigitronics of Connecticut, Inc. · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

58 daysmedian FDA review time
145 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K891282MIC-100 WITH CRYOPROBESFrigitronics of Connecticut, Inc.1989-06-15980
K872362FRIGITRONICS ACC-1000 CAPSULE CUTTERFrigitronics of Connecticut, Inc.1987-07-27390
K853308KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000Frigitronics of Connecticut, Inc.1985-10-04580
K834577I/A PROBE LINESFrigitronics of Connecticut, Inc.1984-05-221450
K840536CRYO SURG 5900Frigitronics of Connecticut, Inc.1984-04-23750
K834437KEATES IRRIGATION/ASPIRATION/VITREOUSFrigitronics of Connecticut, Inc.1984-03-301020
K822599KEATES I/A SYSTEM FRIGITRONICS 4000Frigitronics of Connecticut, Inc.1982-10-06400
K811390CCS100 CRYOSURGICAL SYSTEMFrigitronics of Connecticut, Inc.1981-06-16290
K760742CS-76 AND/OR CRYOCARE IFrigitronics of Connecticut, Inc.1976-11-03340

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