Cleared Traditional

K852062 - SARACAP RESPIRATORY MONITOR

K852062 is an FDA 510(k) clearance for SARACAP RESPIRATORY MONITOR, manufactured by Alleghany Intl. Medical Technology. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K852062 · Alleghany Intl. Medical Technology · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
89d
Days
Class 2
Risk

K852062 is an FDA 510(k) clearance for the SARACAP RESPIRATORY MONITOR. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Alleghany Intl. Medical Technology (St.Louis, US). The FDA issued a Cleared decision on August 6, 1985 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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.

FDA 510(k) Submission Details - K852062

510(k) Number K852062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date August 06, 1985
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 140d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 279
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K852062.
PB 254 IR - SPECTROMETER
K861213 · Datex Division Instrumentarium Corp. · Apr 1986
SERIES 7050 CAPNOGRAPH
K860556 · Marquette Electronics, Inc. · Feb 1986
MULTICAP MULTIGAS CAPNOMETER PB252
K853396 · Instrumentarium Corp. · Aug 1985
CAPNOMED
K851658 · Draeger Medical, Inc. · May 1985
SERIES 7000 END TIDAL CO2 MONITORING SYSTEM
K851001 · Marquette Electronics, Inc. · May 1985
TRI-MED MODEL 112 MOISTURE TRAP
K850745 · Tri-Med, Inc. · Apr 1985
K852062 · SARACAP RESPIRATORY MONITOR
Download PDF Alleghany Intl. Medic…