510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913164Substantially Equivalent

Non Rebreathing Mask

Specialty Packaging Producs, Inc., El Paso TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913164 is the FDA 510(k) clearance record for NON REBREATHING MASK, a class I device, cleared for Specialty Packaging Producs, Inc. on under FDA product code KGB (Mask, Oxygen, Non-Rebreathing). FDA records list 11 510(k) clearances for Specialty Packaging Producs, Inc., from to . As of , FDA records show 6 recalls naming K913164.

Clearance record

Decision date
Received
(182 days to decision)
Product code
KGB Mask, Oxygen, Non-Rebreathing
Regulation
21 CFR 868.5570
Device class
Class I
Review panel
Anesthesiology
Applicant
Specialty Packaging Producs, Inc. 19 Leigh Fisher, El Paso TX
510(k) summary
Summary
Third party review
No

Clearances, product code KGB

Trailing 12 months

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

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