X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

Supplement S054 to premarket approval P160022. Product code MKJ. Decision 2 October 2026.

Approval

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
PMA number	P160022	pma_number
Supplement number	S054	supplement_number
Applicant	ZOLL Medical Corporation	applicant
Trade name	X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™	trade_name
Generic name	Automated external defibrillators (non-wearable)	generic_name
Product code	MKJ	product_code
Advisory committee	Cardiovascular	advisory_committee_description
Date received	2026-09-04	date_received
Decision date	2026-10-02	decision_date
Decision code	OK30	decision_code
Supplement type	30-Day Notice	supplement_type
Supplement reason	Process Change - Manufacturer/Sterilizer/Packager/Supplier	supplement_reason

Source: FDA openFDA, device/pma, P160022/S054, retrieved 2026-10-15 16:01 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

MKJ

Automated External Defibrillators (Non-Wearable)

Device class 3 · Regulation 870.5310 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

MKJ is one of the 60 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 15 October 2026.

Supplement history

Every record of this PMA number in ArrHub’s verified view, newest first. Routine notices are listed, never summarised away.

Record	Type	Reason	Decision
P160022/S054 FDA	30-Day Notice	Process Change - Manufacturer/Sterilizer/Packager/Supplier	2026-10-02

Source: FDA openFDA, device/pma, records of P160022, retrieved 2026-10-15 16:01 Eastern. 1 record in the verified view. Each identifier links to the FDA’s page.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

Record pair

No confirmed pair across the two registers for this record.

Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

First seen by ArrHub’s weekly snapshot: 2026-10-15 17:24 Eastern.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/pma.json?search=pma_number:P160022+AND+supplement_number:S054&limit=1

{
  "id": "7f3e7f65-6b24-4ea0-b0f4-bb346f691521",
  "pma_key": "P160022/S054",
  "pma_number": "P160022",
  "supplement_number": "S054",
  "applicant": "ZOLL Medical Corporation",
  "trade_name": "X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower",
  "generic_name": "Automated external defibrillators (non-wearable)",
  "product_code": "MKJ",
  "advisory_committee_description": "Cardiovascular",
  "decision_date": "2026-10-02",
  "decision_code": "OK30",
  "supplement_type": "30-Day Notice",
  "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
  "date_received": "2026-09-04",
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160022&s=S054",
  "verified_at": "2026-10-15T21:05:48.67+00:00",
  "created_at": "2026-10-15T20:01:55.624421+00:00",
  "collected_at": "2026-10-15T20:01:55.441+00:00",
  "last_checked_at": "2026-10-15T21:05:48.67+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

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