510(k) · Cleared

Cleared

JMS Bypass Tube

K032977510(k) TraditionalCleared May 25, 2004244-day reviewClass II21 CFR 870.4210

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

Jms North America Corp. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on May 25, 2004 as substantially equivalent to K990396 (Edwards Lifesciences Research Medical, 1999) after a 244-day review. Its family tree reaches back 2 generations to 1997.

Decided: May 25, 2004
Review: 244 days
Class: Class II
Product code: DWF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K972261 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK972261 Rivetti-Levinson Instraluminal ShuntIntegra Neurocare, LLC · 1997
1 generation backK990396 T-AnastafloEdwards Lifesciences Research Medical · 1999 · Recalled
This deviceK032977 JMS Bypass TubeJms North America Corp. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K972261	Rivetti-Levinson Instraluminal Shunt	Integra Neurocare, LLC	1997	—
−1	K990396	T-Anastaflo	Edwards Lifesciences Research Medical	1999	1
0 (this device)	K032977	JMS Bypass Tube	Jms North America Corp.	2004	—

FIG. 1 — Lineage of K032977, 1997–2004Source: 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 DWF? 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 DWF device

#1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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
*	K990396	T-Anastaflo Summary page 1 …:JMS Bypass Tube Ill. Substantial Equivalence Predicate Device Name : T-AnastaFLO 510(K) Number : K990396 Manufacturer :Baxter Research Medical, Inc. SE Decision Date :Oct 1st, 1999 I…	Edwards Lifesciences Research Medical	1999	1

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 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2007high 358 (2021) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DWF

4in 2024

2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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	2	—	25	121
2008	6	95	25	126
2009	8	148	21	99
2010	3	62	26	197
2011	5	85	13	212
2012	10	110	37	233
2013	9	110	14 (1)	238
2014	14	110	6	325
2015	9	46	3 (1)	218
2016	3	32	3	144
2017	5	127	2 (1)	101
2018	5	30	10	118
2019	3	120	2	179
2020	3	30	0	142
2021	5	358	3	162
2022	2	—	0	276
2023	2	—	0	470
2024	3	29	4	401
2025	4	89	0	1,020
2026	8	81	20	—

What is it indicated for?

JMS Bypass Tube is intended to be used to internally shunt blood vessel during anastomosis constructions. The shunt allows blood to be delivered distally past the anastomosis site preventing ischemia while the target coronary artery is opened and surgical grafted to a donor vessel. The bypass shunt is to be removed prior to the final sutures being performed. Select the blood vessel bypass tube which is appropriate for the internal diameter of the blood vessel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032977 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032977: JMS Bypass Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032977

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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