Cleared Abbreviated

INFANT PLETHYSMOGRAPH, MODEL 004400 (K011344) - FDA 510(k) Clearance

Also marketed or referenced as:
PEDIATRIC PLETHYSMOGRAPH, MODEL 004400

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K011344 · Collins Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
380d
Days
Class 2
Risk

K011344 is an FDA 510(k) clearance for the INFANT PLETHYSMOGRAPH, MODEL 004400. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Collins Medical, Inc. (Washington, US). The FDA issued a Cleared decision on May 17, 2002 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Collins Medical, Inc. devices

Submission Details

510(k) Number K011344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2001
Decision Date May 17, 2002
Days to Decision 380 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 140d · This submission: 380d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 7
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K802920 · C.R. Bard, Inc. · Feb 1981