510(k) Report

510(k) · Cleared

Cleared

Zoll PD 5300

K931787510(k) TraditionalCleared Oct 15, 1993186-day reviewClass II21 CFR 870.5300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zoll Medical Corp · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

Cleared on Oct 15, 1993 after a 186-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.

Decided
Oct 15, 1993
Review
186 days
Class
Class II
Product code
LDD
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant cleared2014: 3 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK931787 Zoll PD 5300Zoll Medical Corp · 1993
  2. Descendant · cites it directly · 7 of its ownK110978 Onestep Pediatric Mfe'sZOLL Medical Corporation · 2011
  3. Descendant · 2 generations on · 6 of its ownK120907 Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012
  4. Descendant · 3 generations on · 4 of its ownK133269 Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014
  5. Descendant · 4 generations on · 2 of its ownK141774 Zoll X SeriesZOLL Medical Corporation · 2014
  6. Descendant · 5 generations on · 1 of its ownK202375 ZOLL Propaq MZOLL Medical Corporation · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 32015: 12021: 12024: 1
2011high 3 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all
  • K110978Onestep Pediatric Mfe'sZOLL Medical Corporation · 2011 · cites it directly7descendants
  • K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters · 2012 · 2 generations on6descendants
  • K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters · 2014 · 3 generations on4descendants
  • K141774Zoll X SeriesZOLL Medical Corporation · 2014 · 4 generations on2descendants
  • K202375ZOLL Propaq MZOLL Medical Corporation · 2021 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931787Zoll PD 5300Zoll Medical Corp1993—
+1K110978Onestep Pediatric Mfe'sZOLL Medical Corporation2011—
+2K120907Zoll R SeriesZoll Medical Corporation, World Wide Headquarters2012—
+3K133269Zoll X SeriesZoll Medical Corporation, World Wide Headquarters2014—
+4K141774Zoll X SeriesZOLL Medical Corporation2014—
+5K202375ZOLL Propaq MZOLL Medical Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201430
201510
202110
202410
FIG. 1 — Lineage of K931787, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LDD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LDD device

  1. #1 K200849 Tempus LS - Manualscore 1.3 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110978Onestep Pediatric Mfe'sZOLL Medical Corporation20117

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K110978 (ZOLL Medical Corporation, 2011) has gone furthest, with 7 descendants of its own.

How does its category compare?

All LDD devices

LDD Dc-Defibrillator, Low-Energy, (Including Paddles): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDD

1in 2021

2008: 22010: 22011: 42014: 12015: 12019: 12020: 12021: 1
2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDD

124in 2011

2011: 124 days median
2007high 124 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LDD

2in 2024

2008: 112009: 12011: 12014: 2, 2 Class I2020: 12022: 12024: 2
2007high 11 (2008) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LDD

74in 2025

2007: 5502008: 1,2142009: 1,0572010: 6352011: 3862012: 3982013: 6022014: 4812015: 862016: 582017: 492018: 282019: 342020: 192021: 222022: 802023: 2642024: 1602025: 74
2007high 1,214 (2008) · low 19 (2020)2025

MAUDE reports naming product code LDD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0550
20082—111,214
20090—11,057
20102—0635
201141241386
20120—0398
20130—0602
20141—2 (2)481
20151—086
20160—058
20170—049
20180—028
20191—034
20201—119
20211—022
20220—180
20230—0264
20240—2160
20250—074
20260—0—

More from Zoll Medical Corp

33 FDA decisions under this applicant name. See the company

  • K133484Zoll X SeriesZoll Medical Corp · 2014
  • K112660PocketcprZoll Medical Corp · 2012
  • K090989Zoll R Series with Nibp and ETCO2 Options, Zoll R SeriesZoll Medical Corp · 2009
  • K042007Zoll E Series DefibrillatorZoll Medical Corp · 20053 recalls
  • K042302Zoll Autoclavable Internal Handles, Zoll Autoclavable Internal Handles with Integrated Electrodes, Zoll…Zoll Medical Corp · 2004

Recent decisions in LDD

The LDD category page

  • K203231Switched Internal PaddlesPhilips North America, LLC · 2021
  • K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company · 20204 recalls
  • K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc. · 20191 recall
  • K150349Rapid Hair Removal PadsFull Power Aed · 2015
  • K140502Zoll E Series AlsZOLL Medical Corporation · 2014

https://510kreport.com/device/K931787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931787: Zoll PD 5300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931787

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026