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Patient Monitor PB240

by Puritan Bennett Corp.

510(k) K853318

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853318 Date11 Mar 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
DRT
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
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 patient monitor, cardiac (incl. cardiotachometer & rate alarm), as defined in the nomenclature authority. It is a Class II medical device under FDA regulation.

It received FDA 510(k) clearance (K853318) on March 11, 1986, as substantially equivalent to a predicate device. The device is manufactured by Puritan Bennett Corp. and is intended for use in cardiovascular monitoring settings.

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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 PATIENT MONITOR PB240 used for?

    The PATIENT MONITOR PB240 is intended for cardiovascular monitoring settings, providing continuous monitoring of cardiac activity including heart rate and rate alarms, as defined by its classification as a cardiac monitor with cardiotachometer and rate alarm functionality.

  • Who manufactures the PATIENT MONITOR PB240 and where is it made?

    The PATIENT MONITOR PB240 is manufactured by Puritan Bennett Corp., with manufacturing operations based in Overland Park, Kansas, United States, as indicated by the manufacturer's address in the device authorization records.

  • What regulatory pathway was used for the PATIENT MONITOR PB240 and when was it cleared?

    The PATIENT MONITOR PB240 received FDA 510(k) clearance through the traditional pathway on March 11, 1986, under submission K853318, after being found substantially equivalent to a predicate device in the cardiovascular monitoring category.