Atlas FDA

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

Bio Quantum Technologies, Inc. · Predicate Candidate Screening

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

163 daysmedian FDA review time
407 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934089BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MOBio Quantum Technologies, Inc.1994-02-031630
K864946ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USEBio Quantum Technologies, Inc.1988-01-284070
K864887ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SUBio Quantum Technologies, Inc.1987-04-101190
K864948ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USEBio Quantum Technologies, Inc.1987-03-301030
K840406MICROSURGICAL CO2 LASER SYS - 4100Bio Quantum Technologies, Inc.1984-08-202020
K837110MODEL 4100 MICROSURGICAL CO2 LASER SYSTEMBio Quantum Technologies, Inc.1983-03-11630

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