Atlas FDA

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

Sentry Medical Products, Inc. · Predicate Candidate Screening

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

120 daysmedian FDA review time
218 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K962122SENTRY RADIOTRANSLUCENT ECG ELECTRODESSentry Medical Products, Inc.1996-07-24540
K955636SENTRY DISPOSABLE DISPERSIVE ELECTRODESentry Medical Products, Inc.1996-03-271070
K942827SENTRY INSERTION TRAYSentry Medical Products, Inc.1994-11-021410
K934000SENTRY AQUEOUS GEL ECG ELECTRODESSentry Medical Products, Inc.1994-08-303780
K935098BABY BOARDSentry Medical Products, Inc.1994-02-151130
K933603LEADWIRESentry Medical Products, Inc.1994-01-181750
K932704PATIENT CABLESentry Medical Products, Inc.1993-12-272070
K881670ACCUTEMP PLUSSentry Medical Products, Inc.1988-11-222180
K881343DURADERM BUTTERFLYSentry Medical Products, Inc.1988-05-04350
K851522DIAGNOSTIC ECG DISPOSABLE ELECTRODESentry Medical Products, Inc.1985-10-241920
K853552SENTRY FLEXIBLE TENSSentry Medical Products, Inc.1985-09-26310
K844632INFANT LIMB ELECTRODESentry Medical Products, Inc.1985-01-14480
K830362INFANT ELECTRODE BELTSentry Medical Products, Inc.1983-06-031200

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