Atlas FDA

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

Frye Electronics, Inc. — Predicate Candidate Screening

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

66 daysmedian FDA review time
123 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K123701HEARLAB ACAFrye Electronics, Inc.2013-04-051230
K093006FONIX ,MODEL 8000Frye Electronics, Inc.2009-12-30930
K022510FONIX, MODEL 7000Frye Electronics, Inc.2002-08-27280
K980377FONIX FP35 HEARING AID ANALYZERFrye Electronics, Inc.1998-03-18440
K935400FONIX 3500 HEARING AID ANALYZERFrye Electronics, Inc.1994-01-14660
K913221TYPE FA10 AUDIOMETERFrye Electronics, Inc.1991-10-11840
K895383TYPE FP40 DIGITAL HEARING AID ANALYZERFrye Electronics, Inc.1990-01-221450
K872242TYPE 6400 REAL EAR HEARING AID ANALYZERFrye Electronics, Inc.1987-07-10290
K861571TYPE 6500 HEARING AID ANALYZERFrye Electronics, Inc.1986-05-30320
K850918TYPE FP30 DIGITAL HEARING AID ANALYZERFrye Electronics, Inc.1985-05-29850
K833883DIGITAL AUDIOMETER/HEARING AID 3100Frye Electronics, Inc.1984-02-211040
K801905FONIX TYPE 5100 HEARING AID ANALYZERFrye Electronics, Inc.1980-08-27160
K800630TYPE 4000 TRANSCUTANEOUS ELEC. STIM.Frye Electronics, Inc.1980-04-02130

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