510(k) Report

510(k) · Cleared

Cleared

CPR Locator

K833737510(k) TraditionalCleared Aug 24, 1984304-day reviewClass II21 CFR 870.5210

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

Lifepoint,Inc · LIX Aid, Cardiopulmonary Resuscitation

Cleared on Aug 24, 1984 after a 304-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 24, 1984
Review
304 days
Class
Class II
Product code
LIX
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K833737Source: FDA 510(k) database · 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 LIX? 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 LIX device

  1. #1 K201581 CPR Bandscore 1.9 · 4 generations · no Class I recall
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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All LIX devices

LIX Aid, Cardiopulmonary Resuscitation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LIX

1in 2021

2007: 12009: 12012: 22013: 22015: 12018: 22021: 1
2007high 2 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIX

Too few LIX 510(k)s in any year since 2007 to give a median.

Recalls per year · LIX

2in 2018

2018: 2
2007high 2 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LIX

7in 2025

2009: 12012: 92013: 502014: 552015: 12016: 72017: 22018: 32019: 12021: 12023: 102024: 52025: 7
2007high 55 (2014) · low 0 (2007)2025

MAUDE reports naming product code LIX, 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
20071—00
20080—00
20091—01
20100—00
20110—00
20122—09
20132—050
20140—055
20151—01
20160—07
20170—02
20182—23
20190—01
20200—00
20211—01
20220—00
20230—010
20240—05
20250—07
20260—0—
Cite this page

510(k) Report. “K833737: CPR Locator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833737

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