510(k) · Cleared

Cleared

Lifedop Model 300ABI

K093393510(k) TraditionalCleared Dec 24, 200955-day reviewClass II21 CFR 892.1540

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

Summit Doppler Systems, Inc. · JAF Monitor, Ultrasonic, Nonfetal

Cleared on Dec 24, 2009 as substantially equivalent to K024197 (Summit Doppler Systems, Inc., 2003) after a 55-day review. Its family tree reaches back 3 generations to 1994.

Decided: Dec 24, 2009
Review: 55 days
Class: Class II
Product code: JAF
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K930200 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK930200 Multi Dopplex II / Fetal Dopplex IIHuntleigh Healthcare, Inc. · 1994
2 generations backK991441 Cadence Doppler Ultrasound SystemMedasonics, Inc. · 1999
1 generation backK024197 Lifedop DopplerSummit Doppler Systems, Inc. · 2003 · Recalled
This deviceK093393 Lifedop Model 300ABISummit Doppler Systems, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K930200	Multi Dopplex II / Fetal Dopplex II	Huntleigh Healthcare, Inc.	1994	—
−2	K991441	Cadence Doppler Ultrasound System	Medasonics, Inc.	1999	—
−1	K024197	Lifedop Doppler	Summit Doppler Systems, Inc.	2003	1
0 (this device)	K093393	Lifedop Model 300ABI	Summit Doppler Systems, Inc.	2009	—

FIG. 1 — Lineage of K093393, 1994–2009Source: 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 JAF? 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 JAF device

#1 K242487 Laminar P1 (LDH-HW-001)score 10.3 · 7 generations · no Class I recall

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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
*	K024197	Lifedop Doppler Summary page 1 …lence: Summit Doppler Systems Golden, CO LifeDop Doppler Ultrasound System K024 197, Cleared 1/3/03 Technologies Summary: Doppler ultrasound technology is the same as substantially equivalent…	Summit Doppler Systems, Inc.	2003	1
†	K063600	Vista Avs	Summit Doppler Systems, Inc.	2006	—

Also cleared against K024197: 6 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?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
1 of the 3 ancestors has a recall of any class.
6 other devices also cite its predicate K024197.

How does its category compare?

All JAF devices

JAF Monitor, Ultrasonic, Nonfetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JAF

1in 2024

2007high 2 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAF

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

Recalls per year · JAF

No recall names JAF since 2007.

Adverse event reports per year · JAF

1in 2023

2007high 44 (2017) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	1	—	0
2009	2	—	0
2010	0	—	1
2011	1	—	0
2012	0	—	1
2013	0	—	2
2014	0	—	8
2015	1	—	7
2016	0	—	5
2017	0	—	44
2018	0	—	1
2019	0	—	2
2020	0	—	5
2021	0	—	1
2022	0	—	2
2023	0	—	1
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093393: Lifedop Model 300ABI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093393

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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