510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K881858Substantially Equivalent

Ace Icpm Side Ported Needle

Buckman Co., Inc., Martinez CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881858 is the FDA 510(k) clearance record for ACE ICPM SIDE PORTED NEEDLE, cleared for Buckman Co., Inc. on under FDA product code LXC (Monitor, Pressure, Intracompartmental). FDA records list 111 510(k) clearances for Buckman Co., Inc., from to . As of , FDA records show no recalls naming K881858.

Clearance record

Decision date
Received
(24 days to decision)
Product code
LXC Monitor, Pressure, Intracompartmental
Device class
Unclassified
Review panel
Unknown
Applicant
Buckman Co., Inc. 921 Calle Verde, Martinez CA
Third party review
No

Clearances, product code LXC

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