Atlas FDA

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

Bio-Feedback Systems, Inc. — Predicate Candidate Screening

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

23 daysmedian FDA review time
132 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905372MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002Bio-Feedback Systems, Inc.1991-04-121340
K905373MINIATURE TEMPERATURE TRAINER MODEL DT-002Bio-Feedback Systems, Inc.1991-04-101320
K900063MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)Bio-Feedback Systems, Inc.1990-02-16440
K860914ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONVBio-Feedback Systems, Inc.1986-06-06870
K832333FEEDBACK EMG SYSTEM PE-020Bio-Feedback Systems, Inc.1983-09-01450
K812619ISOLATED VOLTAGE/FREQUENCY CONVERTERBio-Feedback Systems, Inc.1981-10-08230
K792659FEEDBACK EDR SYSTEM MODEL ME-1Bio-Feedback Systems, Inc.1980-01-09140
K771023ANALOG QUANTIFIER MODEL AQ-100Bio-Feedback Systems, Inc.1977-06-24160
K770790FEEDBACK EDR SYSTEM MODEL EDR-100Bio-Feedback Systems, Inc.1977-05-1080
K770663FEEDBACK EMG SYSTEM, MODEL PE-L00Bio-Feedback Systems, Inc.1977-04-26190
K770270TEMPERATURE FEEDBACK SYS, MODEL DT100Bio-Feedback Systems, Inc.1977-02-24130

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