Cleared Traditional

K873684 - ACE INTRA COMPARTMENTAL PRESSURE MONITOR

K873684 · Ace Medical Co. · Orthopedic device
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Jan 1988
Decision
128d
Days
-
Risk

K873684 is an FDA 510(k) clearance for the ACE INTRA COMPARTMENTAL PRESSURE MONITOR. Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Ace Medical Co. (Martinez, US). The FDA issued a Cleared decision on January 20, 1988 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ace Medical Co. devices

FDA 510(k) Submission Details - K873684

510(k) Number K873684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1987
Decision Date January 20, 1988
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 10
Devices cleared under the same product code (LXC) and FDA review panel - the closest regulatory comparables to K873684.
MY01 Continuous Compartmental Pressure Monitor
K193321 · MY01, Inc. · Jul 2020
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555 · Synthes (Usa) · Jul 2003
ACE ICPM SIDE PORTED NEEDLE
K881858 · Buckman Co., Inc. · May 1988
COMPARTMENT SYNDROME PRESSURE MONITOR SYS
K844214 · Stryker Corp. · Apr 1985