Cleared Traditional

K990960 - PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)

K990960 is an FDA 510(k) clearance for PERIMED TRANSCUTANEOUS PO2 AND PCO2 MON..., manufactured by Perimed, Inc.. The device is a Class 2 Anesthesiology device with product code LKD cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K990960 · Perimed, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
185d
Days
Class 2
Risk

K990960 is an FDA 510(k) clearance for the PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040). Classified as Monitor, Carbon-dioxide, Cutaneous (product code LKD), Class II - Special Controls.

Submitted by Perimed, Inc. (Laurel, US). The FDA issued a Cleared decision on September 23, 1999 after a review of 185 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2480 - the FDA anesthesiology and respiratory device framework. 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K990960

510(k) Number K990960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1999
Decision Date September 23, 1999
Days to Decision 185 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 140d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKD Device Classification - Class 2, Special Controls

Product Code LKD Monitor, Carbon-dioxide, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2480
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - LKD Monitor, Carbon-dioxide, Cutaneous

All 15
Devices cleared under the same product code (LKD) and FDA review panel - the closest regulatory comparables to K990960.
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K913013 · S & W Medico Teknik · May 1994
HBO CABLE ASSEMBLY, RADIOMETER TC-02
K905225 · Sechrist · Apr 1991
K990960 · PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
Download PDF FDA Summary Perimed, Inc.