510(k) · Cleared

Cleared

Edac Quantifier

K071231510(k) TraditionalCleared May 17, 200714-day reviewClass II21 CFR 870.4205

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

Luna Innovations, Inc. · KRL Detector, Bubble, Cardiopulmonary Bypass

Cleared on May 17, 2007 as substantially equivalent to K940651 (3M Health Care, Sarns, 1994) after a 14-day review. Its family tree reaches back 1 generation to 1994.

Decided: May 17, 2007
Review: 14 days
Class: Class II
Product code: KRL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K940651 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK940651 Sarns Ultrasonic Air Sensor3M Health Care, Sarns · 1994
This deviceK071231 Edac QuantifierLuna Innovations, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940651	Sarns Ultrasonic Air Sensor	3M Health Care, Sarns	1994	—
0 (this device)	K071231	Edac Quantifier	Luna Innovations, Inc.	2007	—

FIG. 1 — Lineage of K071231, 1994–2007Source: 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 KRL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

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
*	K940651	Sarns Ultrasonic Air Sensor Summary page 1 …ss circuit line. It is substantially equivalent to the Sarns Ultrasonic Air Sensor that was cleared for marketing by the FDA following review of Sarns' 510(k) submission K94065 1. Both the EDACTM QUANTIFIER and Sans Ultrasonic Air Sensor use ultrasound detection modality and therefore detect gas emboli in…	3M Health Care, Sarns	1994	—

Also cleared against K940651: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K940651.

How does its category compare?

All KRL devices

KRL Detector, Bubble, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KRL

1in 2011

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRL

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

Recalls per year · KRL

1in 2010

2007high 3 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KRL

4in 2024

2007high 26 (2008) · low 0 (2013)2025

MAUDE reports naming product code KRL, 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	—	3	10
2008	0	—	0	26
2009	1	—	0	5
2010	0	—	1	3
2011	1	—	0	1
2012	0	—	0	1
2013	0	—	0	0
2014	0	—	0	1
2015	0	—	0	6
2016	0	—	0	18
2017	0	—	0	11
2018	0	—	0	2
2019	0	—	0	4
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	20
2023	0	—	0	17
2024	0	—	0	4
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The EDACTM QUANTIFIER has the intended use as a standalone accessory to detect gaseous emboli in an extracorporeal bypass circuit line.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071231 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071231: Edac Quantifier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071231

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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