Atlas FDA

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

Eaton Medical Group · Predicate Candidate Screening

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

108 daysmedian FDA review time
271 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K851623MODEL TRC-40 TELEMETRY RECIEVER MODULEEaton Medical Group1986-01-222790
K851624MODEL TT-185 TELEMETRY TRANSMITTEREaton Medical Group1986-01-142710
K851625SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000Eaton Medical Group1985-11-192150
K851632PCX-100 PATIENT INPUT LEADWIREEaton Medical Group1985-11-082040
K851627KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTREaton Medical Group1985-11-082040
K851631TMX-C1/C2 TRADMILL CONTROLLER ACCESS.Eaton Medical Group1985-07-15880
K851629TMX-70 TREADMILLEaton Medical Group1985-07-09820
K851630TMX-80 TREADMILLEaton Medical Group1985-07-09820
K851628RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTROEaton Medical Group1985-06-27700
K851633CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 ELEaton Medical Group1985-06-26690
K851626SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELEEaton Medical Group1985-06-26690
K850323TELEMETRY SOFTWARE FOR G-2000 ELECTROCARDIOGRAPHEaton Medical Group1985-05-161080
K850322RESTING ECG SOFTWARE FRO G-2000 ELECTROCARDIOGRAPHEaton Medical Group1985-05-161080
K850365RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 REEaton Medical Group1985-04-09690
K832227G-2000Eaton Medical Group1983-12-011460

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