510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951157Substantially Equivalent

Dx1-Portable

Creative Biomedics, Inc., San Clemente CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951157 is the FDA 510(k) clearance record for DX1-PORTABLE, a class II device, cleared for Creative Biomedics, Inc. on under FDA product code BZC (Calculator, Pulmonary Function Data). FDA records list 4 510(k) clearances for Creative Biomedics, Inc., from to . As of , FDA records show no recalls naming K951157.

Clearance record

Decision date
Received
(150 days to decision)
Product code
BZC Calculator, Pulmonary Function Data
Regulation
21 CFR 868.1880
Device class
Class II
Review panel
Anesthesiology
Applicant
Creative Biomedics, Inc. 934-B Calle Negocio, San Clemente CA
510(k) summary
Statement
Third party review
No

Clearances, product code BZC

Trailing 12 months

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

FDA records show no clearances under product code BZC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZC, 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