Medical Device Manufacturer · US , Pleasantville , NY

Ppg Industries, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 1987
20
Total
20
Cleared
0
Denied

Ppg Industries, Inc. is a global manufacturer of paints, coatings, and specialty products headquartered in Pittsburgh, Pennsylvania, with a manufacturing facility in Pleasantville, US. The company operates in more than 50 countries and reported net sales of $15.9 billion in 2025.

PPG Industries received 20 FDA 510(k) clearances from 20 total submissions, with all submissions resulting in clearance. The company's regulatory activity focused on cardiovascular devices, including physiological monitoring systems, recording equipment, and transducer catheters. Clearances span from 1987 to 1992, establishing a historical record in medical device regulation.

Notable cleared devices include the MIDAS SYSTEM physiological monitoring platforms, CARDIOTEST and CARDIOGNOST electrocardiography systems, and PPG BIOMEDICAL flexible micro transducer catheters. These products reflect the company's expertise in cardiac monitoring and diagnostic instrumentation during the late 1980s and early 1990s.

This company profile represents a historical regulatory record. For detailed information on specific device names, product codes, and individual clearance dates, review the complete FDA 510(k) submission history.

FDA 510(k) Regulatory Record - Ppg Industries, Inc.
20 devices
1-20 of 20
Cleared Nov 10, 1992
STATPAL II BLOOD GAS ANALYSIS SYSTEM
K922631 · CHL
Chemistry · 160d
Cleared Dec 20, 1991
MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST
K913358 · DXG
Cardiovascular · 144d
Cleared Nov 29, 1991
STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL
K914560 · CHL
Chemistry · 45d
Cleared Sep 10, 1991
MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM
K912627 · MHX
Cardiovascular · 88d
Cleared Dec 26, 1990
STATPAL BLOOD GAS MONITORING SYSTEM
K903965 · CHL
Chemistry · 120d
Cleared Nov 16, 1990
XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.
K901514 · DSK
Cardiovascular · 231d
Cleared Jul 03, 1990
CARDIOTEST EK 53 R, CARDIOGNOST EK 56/ EK 512
K900246 · DSI
Cardiovascular · 167d
Cleared May 22, 1990
SARA SATCAP
K901132 · CCK
Anesthesiology · 71d
Cleared Apr 16, 1990
PPG BIOMEDICAL VENTILATOR MODEL IRISA
K896442 · CBK
Anesthesiology · 158d
Cleared Apr 03, 1990
SMU 611 UNIVERSALMONITOR
K900700 · DPS
Cardiovascular · 50d
Cleared Oct 17, 1989
CARDIOTEST EK53/EK53R, CARDIOGNOST EK56/EK512
K890875 · DPS
Cardiovascular · 238d
Cleared Oct 12, 1989
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K894286 · DXO
Cardiovascular · 111d
Cleared Apr 19, 1989
PHOTOCHROMIC LENS
K890725 · HQY
Ophthalmic · 65d
Cleared Jan 17, 1989
THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER
K884158 · CCK
Anesthesiology · 105d
Cleared Dec 27, 1988
ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301
K880505 · DSI
Cardiovascular · 326d
Cleared Oct 17, 1988
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K883436 · DXO
Cardiovascular · 63d
Cleared Jun 02, 1988
WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION
K880879 · DQK
Cardiovascular · 93d
Cleared May 13, 1988
RM-301 PATIENT MONITOR
K880498 · DRT
Cardiovascular · 98d
Cleared Feb 29, 1988
NON-INVASIVE BLOOD PRESSURE MODULE
K875265 · DXN
Cardiovascular · 69d
Cleared May 29, 1987
PPG BIOMEDICAL VENTILATOR MODEL AV 400
K871433 · CBK
Anesthesiology · 46d
Filters