Atlas FDA

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

HFM — Predicate Candidate Screening

23 FDA 510(k) clearances under this product code; the 50 most recent screened below.

126 daysmedian FDA review time
230 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140163KOALA TOCOClinical Innovations, LLC2014-05-291270
K061044FEATHERLITE AQUA TOCODYNAMOMETERVentrex, Inc.2006-07-12890
K040392TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORAmerican I.V. Products, Inc.2004-09-142100
K013477TOCO LITE, MODEL TD-01Ventrex, Inc.2002-01-17900
K994353SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #356Precision Dynamics Corp.2000-03-22900
K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITOREpic Medical Equipment Services, Inc.2000-01-181510
K954847DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIESOcg Systems, Inc.1996-05-222120
K952579TOCO TRANSDUCERScientific Device Manufacturer, LLC1995-08-04600
K920152BUBBLE TOCOUtah Medical Products, Inc.1993-05-264990
K910282MEDI-TRACE(R) DISPOSABLE TOCOTONOMETERGraphic Controls Corp.1991-03-29650
K904691AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYSTAir-Shields Vickers, Inc.1991-02-191260
K903623MODEL600 UTERINE ACTIVITY MONITORCorometrics Medical Systems, Inc.1990-11-07900
K902104ORION WATCHGUARDOrion Industries1990-10-251700
K894030MODEL 37 UTERINE CONTRACTION ACTIVITY MONITORHealthdyne, Inc.1990-01-222300
K893770TERM GUARD II DEVICETokos Medical Corp.1989-11-031650
K891997CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCERCorometrics Medical Systems, Inc.1989-06-08720
K882080MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.Aequitron Medical, Inc.1989-03-012880
K873150PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.Pediatric Diagnostic Service1988-03-112130
K874631HEALTHPHONE TOCO MODELCarelink1988-03-111220
K860933AIR-CUSHION TOCOTONOMETERInternational Biomedics, Inc.1986-07-091190
K853856EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMETAequitron Medical, Inc.1986-03-121770
K843011TERM GUARD 5000 UTERINE ACTIVITYTokos Medical Corp.1984-11-01930
K840747TOCO DATA TELEPHONE TRANSMITTER DT100PAdvantage Medical Systems, Inc.1984-06-191170

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