510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945727Substantially Equivalent

Catco Neonatal Palate Guard

Catco Medical, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945727 is the FDA 510(k) clearance record for CATCO NEONATAL PALATE GUARD, a class I device, cleared for Catco Medical, Inc. on under FDA product code BRW (Protector, Dental). FDA records list 12 510(k) clearances for Catco Medical, Inc., from to . As of , FDA records show no recalls naming K945727.

Clearance record

Decision date
Received
(15 days to decision)
Product code
BRW Protector, Dental
Regulation
21 CFR 868.5820
Device class
Class I
Review panel
Anesthesiology
Applicant
Catco Medical, Inc. 9010 Foxland Dr., San Antonio TX
510(k) summary
Statement
Third party review
No

Clearances, product code BRW

Trailing 12 months

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

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