510(k) · Cleared

Cleared

Deepvessel FFR

K213657510(k) TraditionalCleared Apr 1, 2022133-day reviewClass II21 CFR 870.1415

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

Keyamed Na, Inc. · PJA Coronary Vascular Physiologic Simulation Software

Cleared on Apr 1, 2022 as substantially equivalent to K161772 (HeartFlow, Inc., 2016) after a 133-day review. Its family tree reaches back 3 generations to 2014.

Decided: Apr 1, 2022
Review: 133 days
Class: Class II
Product code: PJA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to DEN130045 (2014). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backDEN130045 Heartflow FfrctHeartflow · 2014
2 generations backK152733 FFRctHeartFlow, Inc. · 2016
1 generation backK161772 FFRctHeartFlow, Inc. · 2016
This deviceK213657 Deepvessel FFRKeyamed Na, Inc. · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	DEN130045	Heartflow Ffrct	Heartflow	2014	—
−2	K152733	FFRct	HeartFlow, Inc.	2016	—
−1	K161772	FFRct	HeartFlow, Inc.	2016	—
0 (this device)	K213657	Deepvessel FFR	Keyamed Na, Inc.	2022	—

FIG. 1 — Lineage of K213657, 2014–2022Source: 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 PJA? 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 PJA device

#1 K250902 HeartFlow Analysisscore 13.0 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	K161772	FFRct Summary page 4 …R Classification Name: Coronary Vascular Physiologic Simulation Software Regulatory Class: Class II Product Code: PJA Predicate Device: HEARTFLOW, INC.’s FFRCT V2.0 (K161772) Device Description DEEPVESSEL FFR is a coronary physiological simulation sof tware f or the clinical quantitative and qualitat…	HeartFlow, Inc.	2016	—

Also cleared against K161772: 2 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 8 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K161772.

How does its category compare?

All PJA devices

PJA Coronary Vascular Physiologic Simulation Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · PJA

1in 2025

2007high 2 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PJA

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

Recalls per year · PJA

No recall names PJA since 2007.

Adverse event reports per year · PJA

16in 2025

2007high 65 (2019) · low 0 (2007)2025

MAUDE reports naming product code PJA, 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	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	1	—	0
2015	0	—	0
2016	2	—	0
2017	0	—	4
2018	1	—	12
2019	1	—	65
2020	0	—	9
2021	1	—	2
2022	2	—	1
2023	0	—	8
2024	0	—	14
2025	1	—	16
2026	1	—	—

What is it indicated for?

DEEPVESSEL FFR is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides DVFFR (a CT-derived FFR measurement) computed from static coronary CTA images using deep learning neural networks that encode imaging, structural, and functional characteristics of coronary arteries…

Read the full statement (128 words)

DEEPVESSEL FFR analysis is intended to support the functional evaluation of coronary artery disease. The results of the analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. DEEPVESSEL FFR results are intended to be used by qualified clinicians in conjunction with the with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K213657 · printed Nov 6, 2026

Cite this page

510(k) Report. “K213657: Deepvessel FFR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213657

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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