Cleared Traditional

K881858 - ACE ICPM SIDE PORTED NEEDLE (FDA 510(k) Clearance)

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

Submission Details

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
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -

Regulatory Peers - LXC Monitor, Pressure, Intracompartmental

All 14
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