Cleared Traditional

K810585 - SARA

K810585 is an FDA 510(k) clearance for SARA, manufactured by Allied Healthcare Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBS cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K810585 · Allied Healthcare Products, Inc. · Anesthesiology device
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Mar 1981
Decision
20d
Days
Class 2
Risk

K810585 is an FDA 510(k) clearance for the SARA. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Allied Healthcare Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - 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 Allied Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K810585

510(k) Number K810585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1981
Decision Date March 24, 1981
Days to Decision 20 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
120d faster than avg
Panel avg: 140d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBS Device Classification - Class 2, Special Controls

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
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 - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

All 9
Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K810585.
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
K896216 · Hewlett-Packard Co. · Jan 1990
SPECTRAMED RESPIRATORY GAS ANALYZER
K873194 · Draeger Medical, Inc. · Oct 1987
NORMAC ANESTHETIC AGENT MONITOR
K832113 · Datex Division Instrumentarium Corp. · Sep 1983
ENGSTROM EMMA ANESTHETIC GAS MONITOR
K802614 · Lkb Instruments, Inc. · Jan 1981