Cleared Traditional

K881858 - ACE ICPM SIDE PORTED NEEDLE

K881858 · Buckman Co., Inc. · Orthopedic device
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May 1988
Decision
24d
Days
-
Risk

K881858 is an FDA 510(k) clearance for the ACE ICPM SIDE PORTED NEEDLE. Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Buckman Co., Inc. devices

FDA 510(k) Submission Details - K881858

510(k) Number K881858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1988
Decision Date May 27, 1988
Days to Decision 24 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

LXC Device Classification - Class 0,

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -

Regulatory Peers - LXC Monitor, Pressure, Intracompartmental

All 14
Devices cleared under the same product code (LXC) and FDA review panel - the closest regulatory comparables to K881858.
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K060963 · Twin Star Medical · Jun 2006
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K041771 · Twin Star Medical, Inc. · Sep 2004
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · Synthes (Usa) · Jul 2003
ACE INTRA COMPARTMENTAL PRESSURE MONITOR
K873684 · Ace Medical Co. · Jan 1988
COMPARTMENT SYNDROME PRESSURE MONITOR SYS
K844214 · Stryker Corp. · Apr 1985