510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901028Substantially Equivalent

Environmental Control Unit Model 7000

Baylor Biomedical Services, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901028 is the FDA 510(k) clearance record for ENVIRONMENTAL CONTROL UNIT MODEL 7000, a class II device, cleared for Baylor Biomedical Services on under FDA product code IQA (System, Environmental Control, Powered). FDA records list 4 510(k) clearances for Baylor Biomedical Services. As of , FDA records show no recalls naming K901028.

Clearance record

Decision date
Received
(7 days to decision)
Product code
IQA System, Environmental Control, Powered
Regulation
21 CFR 890.3725
Device class
Class II
Review panel
Physical Medicine
Applicant
Baylor Biomedical Services 3707 Gaston Ave., #216, Dallas TX
Third party review
No

Clearances, product code IQA

Trailing 12 months

FDA records hold no clearances under product code IQA in the trailing twelve months.

FDA records show no clearances under product code IQA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IQA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260