When did LIFEPAK® 35 monitor/defibrillator receive FDA clearance or approval?

LIFEPAK® 35 monitor/defibrillator (Submission ID: P160026) was fda approved by the U.S. FDA on 2026-10-29 under the PMA pathway with a review duration of 30 days.

Who is the manufacturer or applicant for LIFEPAK® 35 monitor/defibrillator?

The applicant and sponsor for P160026 is Physio-Control, Inc..

Is P160026 an AI/ML-enabled medical device?

No. This medical device submission is not designated as incorporating AI/ML software algorithms.

FDA Approved Existing Device (Modification) Pathway: PMA

LIFEPAK® 35 monitor/defibrillator

Applicant: Physio-Control, Inc.

Statutory Profile

Legal Standard:

Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)

Product Code:

MKJ

Review Panel:

Cardiovascular

21 CFR Regulation:

Unspecified

Review Velocity Metrics

Date Received:

2026-09-29

Decision Date:

2026-10-29

Total Review Duration:

30 calendar days (30 days)

Official FDA Research Backlinks

Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:

FDA Database Webpage (pmn.cfm) Official Decision Summary PDF Product Classification Database Establishment Registration & Listing

Identified Contacts & Correspondents

David Lennarz

Role: US_AGENT

📞 757-2240177

✉️ david.lennarz@registrarcorp.com

Robbert Vogels

Role: OFFICIAL_CORRESPONDENT

📞 31-43-8080244-x

Matt Bodoh

Role: US_AGENT

📞 425-8674519

✉️ matthew.bodoh@stryker.com

Amiel Cohen

Role: OFFICIAL_CORRESPONDENT

📞 44-0-0750679856-x

Ship Always

Role: US_AGENT

📞 908-3534000

✉️ shawn.barnes@shipallways.com

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