Cleared Traditional

NOVAMETRIX MODEL 505 PULSE OXIMETER (K873078) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K873078 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Sep 1987
Decision
49d
Days
Class 2
Risk

K873078 is an FDA 510(k) clearance for the NOVAMETRIX MODEL 505 PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on September 23, 1987 after a review of 49 days - a notably fast clearance 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: 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 Novametrix Medical Systems, Inc. devices

Submission Details

510(k) Number K873078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1987
Decision Date September 23, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 189
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K873078.
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · Ohmeda Medical · Dec 1987
MODEL 7200A WITH PULSE OXIMETRY
K873065 · Puritan Bennett Corp. · Oct 1987
OHMEDA BIOX 3740 PULSE OXIMETER
K872772 · Ohmeda Medical · Oct 1987
PB240 PATIENT MONITOR/PULSE OXIMETER
K871864 · Puritan Bennett Corp. · Jun 1987
ACCUSAT
K863855 · Datascope Corp. · Jan 1987