510(k) Report

510(k) · Cleared

Cleared

R2 Plate Type Cable-Adaptor #S 175,176

K800937510(k) TraditionalCleared May 23, 198032-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

R2 Corp. · LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

Cleared on May 23, 1980 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
May 23, 1980
Review
32 days
Class
Class II
Product code
LDD
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2003: 1 descendant cleared19801990200020102020
  1. This deviceK800937 R2 Plate Type Cable-Adaptor #S 175,176R2 Corp. · 1980
  2. Descendant · cites it directly · 1 of its ownK020701 Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2002
  3. Descendant · 2 generations on · 0 of its ownK024071 Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K020701Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2002 · cites it directly1descendant
  • K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K800937R2 Plate Type Cable-Adaptor #S 175,176R2 Corp.1980—
+1K020701Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery2002—
+2K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
FIG. 1 — Lineage of K800937, 1980–2003Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K020701Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery20021

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, K020701 (Guidant Corporation, Cardiac Surgery, 2002) has gone furthest, with 1 descendant 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 R2 Corp.

9 FDA decisions under this applicant name. See the company

  • K832516Magnatrode Cardiac Monitoring ElectrodeR2 Corp. · 1983
  • K800936R2 Paddle Type Cable-Adaptor #S 170,171R2 Corp. · 1980
  • K800930R2(TM) Ecg Electrode Set-#'S305-306 Etc.R2 Corp. · 1980
  • K800931R2(TM) Ecg Cable-Adaptor #'S 120-121-122R2 Corp. · 1980
  • K800935R2 Apex-Post.,Ant.&Post. Elect.(12 Mods)R2 Corp. · 1980

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/K800937 · printed Nov 6, 2026

Cite this page

510(k) Report. “K800937: R2 Plate Type Cable-Adaptor #S 175,176.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800937

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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