510(k) · Cleared

Cleared

CPR RSQ Assist

K123248510(k) TraditionalCleared Dec 10, 2013419-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

Avantech, Inc. · LIX Aid, Cardiopulmonary Resuscitation

Cleared on Dec 10, 2013 as substantially equivalent to K071321 (Bio-Detek, Inc., 2007) and 1 other predicate after a 419-day review. Its family tree reaches back 1 generation to 2001.

Decided: Dec 10, 2013
Review: 419 days
Class: Class II
Product code: LIX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K010526 (2001). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK010526 Modification to the GripElcare Innovations, Inc. · 2001
This deviceK123248 CPR RSQ AssistAvantech, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010526	Modification to the Grip	Elcare Innovations, Inc.	2001	—
0 (this device)	K123248	CPR RSQ Assist	Avantech, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K123248, 2001–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K201581 CPR Bandscore 1.9 · 4 generations · no Class I recall

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K071321	Pocketcpr Summary page 1 …Cardiopulmonary Resuscitation Aid Classification Name 21 CFR 870.5200 Cardiopulmonary Resuscitation Aid Predicate Devices Bio-Detek, Inc.'s PocketCPR (K071321) Elcare Innovations, Inc.'s The Grip (KO 10526) Intended Use / Indications for Use The CPR RsQ Ass…	Bio-Detek, Inc.	2007	—
*	K010526	Modification to the Grip Summary page 2 …993-1. Substantial Equivalence The CPR RsQ Assist is as safe and effective as Bio-Detek, Inc.'s PocketCPR (K07 1321) and Elcare Innovations, Inc.'s The Grip (K0 10526). The CPR RsQ Assist has the same intended uses and similar indications, technological characteristics, and principles of…	Elcare Innovations, Inc.	2001	—

Also cleared against K071321: 4 other devices →

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.

What does this lineage say?

None of the 2 ancestors has a recall.
4 other devices also cite its predicate K071321.

How does its category compare?

All LIX devices

LIX Aid, Cardiopulmonary Resuscitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LIX

1in 2021

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	0	—	0	0
2009	1	—	0	1
2010	0	—	0	0
2011	0	—	0	0
2012	2	—	0	9
2013	2	—	0	50
2014	0	—	0	55
2015	1	—	0	1
2016	0	—	0	7
2017	0	—	0	2
2018	2	—	2	3
2019	0	—	0	1
2020	0	—	0	0
2021	1	—	0	1
2022	0	—	0	0
2023	0	—	0	10
2024	0	—	0	5
2025	0	—	0	7
2026	0	—	0	—

What is it indicated for?

The CPR RsQ Assist is intended to assist the rescuer in performing chest compressions at the recommended American Heart Association (AHA) rate of 100 compressions/minute on a victim 8 years or older.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123248 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123248: CPR RSQ Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123248

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026