510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K901920Substantially Equivalent

Prime Care Neonatal/pediatric Tracheostomy Tube

Primecare, Inc., Laguna Niguel CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901920 is the FDA 510(k) clearance record for PRIME CARE NEONATAL/PEDIATRIC TRACHEOSTOMY TUBE, a class II device, cleared for Primecare, Inc. on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list one 510(k) clearance for Primecare, Inc. As of , FDA records show no recalls naming K901920.

Clearance record

Decision date
Received
(109 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Primecare, Inc. 23991 Ironhead Ln., Laguna Niguel CA
Third party review
No

Clearances, product code BTO

Trailing 12 months
1 clearance under product code BTO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTO, 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 20261
October 20260