Atlas FDA

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

Pro-Tech, Inc. — Predicate Candidate Screening

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

310 daysmedian FDA review time
485 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940013BODY POSITION INDICATOR, MODEL BPI1Pro-Tech, Inc.1995-05-044850
K940015SNORING MICROPHONE, SM1Pro-Tech, Inc.1995-01-113720
K940014PLM SENSOR, MODEL PLM1Pro-Tech, Inc.1994-11-103100
K924752FREEDOM OXIMETER/EEG DIGITAL INTERFACEPro-Tech, Inc.1993-09-103520
K923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSORPro-Tech, Inc.1992-12-301730
K913396CANNULA STYLE THERMOCOUPLESPro-Tech, Inc.1992-05-222970
K913395EZ-1 SYSTEM RESPIRATORY EFFORT SENSORSPro-Tech, Inc.1992-05-202950

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