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Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400

by Collins Medical, Inc.

510(k) K011344

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK011344 Date17 May 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BZC
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 868.1880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a Calculator, Pulmonary Function Data, specifically an infant and pediatric plethysmograph designed to measure lung volume and airflow in young patients. It functions as a pulmonary function testing device used to assess respiratory mechanics in infants and children.

It is supplied as a reusable medical device intended for use in clinical settings such as hospitals or pulmonary function laboratories. The device has received FDA 510(k) clearance under K011344 and is classified as a Class II medical device under regulation number 868.1880, with product code BZC, and is indicated for use in the field of anesthesiology.

Other devices from Collins Medical, Inc.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Infant Pediatric Plethysmograph Model 004400 used for?

    The device is designed to measure lung volume and airflow in infants and pediatric patients. It functions as a pulmonary function testing device to assess respiratory mechanics in young patients during clinical evaluations.

  • How is the Infant Pediatric Plethysmograph Model 004400 supplied and intended for use?

    It is supplied as a reusable medical device intended for use in clinical settings such as hospitals or pulmonary function laboratories. Reusability allows for repeated applications after proper cleaning and disinfection between patients.

  • What regulatory pathway was used for the Infant Pediatric Plethysmograph Model 004400?

    The device received FDA 510(k) clearance under submission number K011344, demonstrating substantial equivalence to a legally marketed predicate device. This clearance permits its commercial distribution in the United States.