Atlas FDA

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

Argosy Electronics — Predicate Candidate Screening

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

28 daysmedian FDA review time
60 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974242ARGOSY PROGRAMMABLE ONQUEArgosy Electronics1998-01-20690
K971699ARGOSY DYNAMEQArgosy Electronics1997-07-03560
K961729ARGOSY PROGRAMMABLEArgosy Electronics1996-05-29260
K954038K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTArgosy Electronics1995-09-18210
K952452OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROLArgosy Electronics1995-07-06420
K952451CLASS D LINEAR WITH ACTIVE TONE CONTROLArgosy Electronics1995-07-06420
K952450WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROLArgosy Electronics1995-07-06420
K952455IMPROVED MANHATTAN IIArgosy Electronics1995-06-21270
K952453INPUT COMPRSSION LIMITER WITH ACTIVE TONE CONTROLArgosy Electronics1995-06-21270
K952454EXPANDER WITH ACTIVE TONE CONTROLArgosy Electronics1995-06-21270
K944078PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FITArgosy Electronics1994-10-21600
K944077PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAMArgosy Electronics1994-10-12510
K940116COMPLETELY IN THE CANALArgosy Electronics1994-05-031130
K934452HI BANDArgosy Electronics1993-10-13330
K934442LINEAR PLUSArgosy Electronics1993-10-08280
K9344493-CHANNEL K-AMPArgosy Electronics1993-10-08280
K934450MANHATTAN 3-CHANNELArgosy Electronics1993-10-08280
K9344432:1 INPUT COMPRESSIONArgosy Electronics1993-10-08280
K934446POWER MANHATTAN IIArgosy Electronics1993-10-08280
K934448POWER 3-CHANNEL-CLOCKArgosy Electronics1993-10-08280
K934447LINEAR PLUS-POWERArgosy Electronics1993-10-08280
K934444K-AMPArgosy Electronics1993-10-08280
K9344533-CHANNEL CLOCKArgosy Electronics1993-10-08280
K934454MANHATTAN IIArgosy Electronics1993-10-08280

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