510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924541Unknown

Epidural Minipack

Concord/Portex, Keene NH / Traditional, Unknown
FDA source (opens on fda.gov)

K924541 is the FDA 510(k) clearance record for EPIDURAL MINIPACK, a class I device, cleared for Concord/Portex on under FDA product code BYO (Bottle, Blow). FDA records list 23 510(k) clearances for Concord/Portex, from to . As of , FDA records show no recalls naming K924541.

Clearance record

Decision date
Received
(304 days to decision)
Product code
BYO Bottle, Blow
Regulation
21 CFR 868.5220
Device class
Class I
Review panel
Anesthesiology
Applicant
Concord/Portex 15 Kitt St., Keene NH
510(k) summary
Summary
Third party review
No

Clearances, product code BYO

Trailing 12 months

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

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