510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K911970Substantially Equivalent

Nasal/oral 02 Delivery and Gas Sampling Device

Nasorcap Ent., Inc., West Mifflin PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911970 is the FDA 510(k) clearance record for NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE, a class II device, cleared for Nasorcap Ent., Inc. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list one 510(k) clearance for Nasorcap Ent., Inc. As of , FDA records show no recalls naming K911970.

Clearance record

Decision date
Received
(469 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Nasorcap Ent., Inc. 1077 Huston Dr., West Mifflin PA
510(k) summary
Summary
Third party review
No

Clearances, product code CCK

Trailing 12 months
3 clearances under product code CCK in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20261
September 20260
October 20260