Atlas FDA

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

Interspec, Inc. — Predicate Candidate Screening

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

95 daysmedian FDA review time
297 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940671INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLERInterspec, Inc.1994-11-222790
K924231INTERSPEC APOGEE CLAInterspec, Inc.1993-06-142970
K915696INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDEInterspec, Inc.1992-11-243370
K920678ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETERInterspec, Inc.1992-04-02480
K911073PROBE REFILL KITInterspec, Inc.1991-06-06870
K910049INTERSPEC APOGEE, MODIFICATIONInterspec, Inc.1991-04-291120
K903839INTERSPEC APOGEEInterspec, Inc.1990-11-16870
K900155INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLERInterspec, Inc.1990-10-052660
K892944INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515Interspec, Inc.1989-07-19890
K890173INTERSPEC APOGEEInterspec, Inc.1989-04-14870
K862913CARDIOSCAN WITH DOPPLER OPTIONInterspec, Inc.1986-11-04950
K863372SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBESInterspec, Inc.1986-11-04630
K860568ULTRASONIC IMAGING SYSTEM (MODIFIED)Interspec, Inc.1986-08-111780
K860579CARDIOSCAN DOPPLER OPTIONInterspec, Inc.1986-06-301320
K841263CARDIOSCAN - TM BEING APPLIED FORInterspec, Inc.1984-10-192070
K841110NEUROTRACInterspec, Inc.1984-04-30760
K823116NEUROTRACInterspec, Inc.1982-12-07470

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