Environmental Tectonics Corp. is one of 18354 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Environmental Tectonics Corp. - FDA 510(k) Cleared Devices
Recent clearances: O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING), BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER, BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
3
Total
2
Cleared
0
Denied
Environmental Tectonics Corp., is a diversified manufacturer of specialized equipment and systems for training, testing, and research applications. Founded in 1969, the company operates with a manufacturing facility in Southampton, Pennsylvania, and serves multiple markets including aerospace, military, automotive, and medical sectors.
The company has received 2 FDA 510(k) clearances from 3 total submissions. Anesthesiology devices represent the company's primary focus in the medical device regulatory space, with cleared submissions spanning from 2000 to 2010. Historical cleared devices include hyperbaric chambers and operating system software for anesthesia control and record-keeping. The company's regulatory activity in this category is now historical, with no new clearances in the past 15 years.
Environmental Tectonics Corp. maintains a global operational footprint through multiple specialized divisions, including sterilization systems, testing and simulation equipment, and aircrew training platforms. The company's broader portfolio extends beyond FDA-regulated devices into environmental control systems and specialized training solutions for defense and commercial aviation markets.
For detailed information on specific device names, product codes, and individual clearance dates, please review the complete 510(k) submission records in the FDA database.
FDA 510(k) Regulatory Record - Environmental Tectonics Corp.
3 devices