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

Ppg Industries, Inc. — Predicate Candidate Screening

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

105 daysmedian FDA review time
238 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922631STATPAL II BLOOD GAS ANALYSIS SYSTEMPpg Industries, Inc.1992-11-101600
K913358MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYSTPpg Industries, Inc.1991-12-201440
K914560STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPALPpg Industries, Inc.1991-11-29450
K912627MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEMPpg Industries, Inc.1991-09-10880
K903965STATPAL BLOOD GAS MONITORING SYSTEMPpg Industries, Inc.1990-12-261200
K901514XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.Ppg Industries, Inc.1990-11-162310
K900246CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512Ppg Industries, Inc.1990-07-031670
K901132SARA SATCAPPpg Industries, Inc.1990-05-22710
K896442PPG BIOMEDICAL VENTILATOR MODEL IRISAPpg Industries, Inc.1990-04-161580
K900700SMU 611 UNIVERSALMONITORPpg Industries, Inc.1990-04-03500
K890875CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512Ppg Industries, Inc.1989-10-172380
K894286PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETERPpg Industries, Inc.1989-10-121110
K890725PHOTOCHROMIC LENSPpg Industries, Inc.1989-04-19650
K884158THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETERPpg Industries, Inc.1989-01-171050
K880505ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301Ppg Industries, Inc.1988-12-273260
K883436PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETERPpg Industries, Inc.1988-10-17630
K880879WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTIONPpg Industries, Inc.1988-06-02930
K880498RM-301 PATIENT MONITORPpg Industries, Inc.1988-05-13980
K875265NON-INVASIVE BLOOD PRESSURE MODULEPpg Industries, Inc.1988-02-29690
K871433PPG BIOMEDICAL VENTILATOR MODEL AV 400Ppg Industries, Inc.1987-05-29460

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