Cleared Traditional

K880756 - MODEL PM-20A PHYSIOLOGICAL MONITOR

K880756 is an FDA 510(k) clearance for MODEL PM-20A PHYSIOLOGICAL MONITOR, manufactured by Advanced Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K880756 · Advanced Medical Systems, Inc. · Anesthesiology device
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Sep 1988
Decision
215d
Days
Class 2
Risk

K880756 is an FDA 510(k) clearance for the MODEL PM-20A PHYSIOLOGICAL MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Advanced Medical Systems, Inc. (Hamden, US). The FDA issued a Cleared decision on September 27, 1988 after a review of 215 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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.

View all Advanced Medical Systems, Inc. devices

FDA 510(k) Submission Details - K880756

510(k) Number K880756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1988
Decision Date September 27, 1988
Days to Decision 215 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 140d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 578
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K880756.
BM-103 BATTERY MODULE
K883877 · Datex Division Instrumentarium Corp. · Oct 1988
KONTRON PULSE OXIMETER 7840
K873624 · Kontron Instruments, Inc. · Oct 1988
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · Hewlett-Packard Co. · Oct 1988
MRL OXIMETER
K882664 · Medical Research Laboratories, Inc. · Sep 1988
HORIZON 2000 PULSE OXIMETRY AND MODULE
K882273 · Mennen Medical, Inc. · Aug 1988
EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER
K881820 · Edentec Corp. · Jul 1988