Cleared Traditional

K873065 - MODEL 7200A WITH PULSE OXIMETRY

K873065 is an FDA 510(k) clearance for MODEL 7200A WITH PULSE OXIMETRY, manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K873065 · Puritan Bennett Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
82d
Days
Class 2
Risk

K873065 is an FDA 510(k) clearance for the MODEL 7200A WITH PULSE OXIMETRY. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on October 26, 1987 after a review of 82 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K873065

510(k) Number K873065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1987
Decision Date October 26, 1987
Days to Decision 82 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 140d · This submission: 82d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K873065.
OHMEDA 4700 OXICAP MONITOR
K873199 · Ohmeda Medical · Feb 1988
CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104
K873859 · Datex Division Instrumentarium Corp. · Dec 1987
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · Ohmeda Medical · Dec 1987
PULSE-OX
K863857 · Life Design Systems, Inc. · Oct 1987
OHMEDA BIOX 3740 PULSE OXIMETER
K872772 · Ohmeda Medical · Oct 1987
NOVAMETRIX MODEL 505 PULSE OXIMETER
K873078 · Novametrix Medical Systems, Inc. · Sep 1987