Atlas FDA

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

Advanced Medical Systems, Inc. — Predicate Candidate Screening

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

215 daysmedian FDA review time
774 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K955931MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)Advanced Medical Systems, Inc.1996-08-142430
K952031ULTRASOUND TRANSDUCER, MODEL US917Advanced Medical Systems, Inc.1995-07-18780
K940898MODEL IM77 INTRAPARTUM FETAL MONITORAdvanced Medical Systems, Inc.1995-03-013700
K923335ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATIONAdvanced Medical Systems, Inc.1994-07-227740
K932278PFM PROFESSIONAL 7000 SPIROMETERAdvanced Medical Systems, Inc.1993-12-172190
K911657FETAL SCALP SPIRAL ELECTRODEAdvanced Medical Systems, Inc.1991-07-11900
K902190FETAL PULSE DETECTOR MODEL DOP-1Advanced Medical Systems, Inc.1990-10-221590
K894568NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEMAdvanced Medical Systems, Inc.1990-01-091720
K891672PUL-TRON 100K PROFESSIONAL SPIROMETERAdvanced Medical Systems, Inc.1989-06-16870
K880756MODEL PM-20A PHYSIOLOGICAL MONITORAdvanced Medical Systems, Inc.1988-09-272150

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