Cleared Traditional

K904633 - SPIROLOOP, MODIFICATION

K904633 is an FDA 510(k) clearance for SPIROLOOP, manufactured by Pneumedics, Inc.. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K904633 · Pneumedics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
168d
Days
Class 2
Risk

K904633 is an FDA 510(k) clearance for the SPIROLOOP, MODIFICATION. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Pneumedics, Inc. (Milford, US). The FDA issued a Cleared decision on March 12, 1991 after a review of 168 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - 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.

FDA 510(k) Submission Details - K904633

510(k) Number K904633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date March 12, 1991
Days to Decision 168 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 140d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCJ Device Classification - Class 2, Special Controls

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
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 - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 24
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K904633.
PICO SMOKERLYZER, MODEL EC-50
K000962 · Bedfont Scientific, Ltd. · Apr 2000
MICROCO
K950197 · Micro Direct, Inc. · Oct 1996
CO BREATH ANALYSIS MODULE & MONOXOL II
K952694 · Bacharach, Inc. · Jan 1996
CO/CMD-1
K900322 · Spirometrics, Inc. · Apr 1990
VITALOGRAPH-BREATHCO MONITOR
K892524 · Vitalograph , Ltd. · May 1989
VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
K863420 · Vitalograph , Ltd. · Jan 1987
K904633 · SPIROLOOP, MODIFICATION
Download PDF Pneumedics, Inc.