510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K892639Substantially Equivalent

The Original Pulse-Pak

Jones Sales Co., Canal Winchester OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892639 is the FDA 510(k) clearance record for THE ORIGINAL PULSE-PAK, a class II device, cleared for Jones Sales Co. on under FDA product code NFB (Conserver, Oxygen). FDA records list one 510(k) clearance for Jones Sales Co. As of , FDA records show no recalls naming K892639.

Clearance record

Decision date
Received
(176 days to decision)
Product code
NFB Conserver, Oxygen
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Jones Sales Co. 4109 Ravine Dr., Canal Winchester OH
Third party review
No

Clearances, product code NFB

Trailing 12 months

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

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