510(k) · Cleared

Recalled · Class II · 2014

Biocardia Morph Sheath Guide

K090999510(k) TraditionalCleared Apr 15, 20097-day reviewClass II21 CFR 870.1340Recalls 3

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

Biocardia, Inc. · DYB Introducer, Catheter

Cleared on Apr 15, 2009 as substantially equivalent to K042553 (Biocardia, Inc., 2005) and 2 other predicates after a 7-day review. Its family tree reaches back 5 generations to 1989. It has been recalled 3 times.

Decided: Apr 15, 2009
Review: 7 days
Class: Class II
Product code: DYB
Recalls: 3
Predicates: 3

Its longest line of descent runs back 5 generations to K893658 (1989). 43 ancestors in all, the oldest K770977 (1977). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
4 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
3 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
2 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
1 generation backK043489 Enpath Deflectable CatheterEnpath Medical Incorporated · 2005 · Recalled
This deviceK090999 Biocardia Morph Sheath GuideBiocardia, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K893658	Percutaneous Introducer	Medamicus, Inc.	1989	—
−4	K965167	Percutaneous Venous Introducer 10264	Medamicus, Inc.	1997	—
−3	K012130	Attain LDS 6216 Left-Heart Delivery System	Medtronic Vascular	2001	—
−2	K013517	10600 Deflectable Catheter System, Model 10600	Medtronic Vascular	2002	—
−1	K043489	Enpath Deflectable Catheter	Enpath Medical Incorporated	2005	2
0 (this device)	K090999	Biocardia Morph Sheath Guide	Biocardia, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1977	1	0
1985	2	0
1986	1	0
1987	3	0
1988	1	0
1990	5	0
1991	1	0
1992	3	0
1993	1	0
1994	4	0
1995	3	0
1996	3	0
1997	1	0
1999	2	0
2001	3	0
2002	1	0
2005	2	0
2008	1	0

FIG. 1 — Lineage of K090999, 1989–2009Source: 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 DYB? 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 DYB device

#1 K251051 AuST Steerable Sheathscore 18.0 · 10 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? (3)

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
*	K042553	Biocardia Morph Universal Deflectable Guide Catheter Summary page 1 …ject device is substantially equivalent in intended use and/or method of operation to the following devices: BioCardia Morph® Universal Deflectable Guide Catheter K042553 Enpath / Bard® Channel Steerable Sheath K043489 Pinnacle® Destination® Peripheral Guiding Sheath K…	Biocardia, Inc.	2005	—
*	K043489	Enpath Deflectable Catheter Summary page 1 …d of operation to the following devices: BioCardia Morph® Universal Deflectable Guide Catheter K042553 Enpath / Bard® Channel Steerable Sheath K043489 Pinnacle® Destination® Peripheral Guiding Sheath K080415 BioCardia, Inc. CONFIDENTIAL…	Enpath Medical Incorporated	2005	2
*	K080415	Device Modification to Pinnacle Destination Peripheral Guiding Sheath Summary page 1 …Deflectable Guide Catheter K042553 Enpath / Bard® Channel Steerable Sheath K043489 Pinnacle® Destination® Peripheral Guiding Sheath K080415 BioCardia, Inc. CONFIDENTIAL Page 8 Morph Sheath Guid…	Terumo Medical Corp.	2008	—

Also cleared against K042553: 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)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 3, 2014	Class II	Z-1301-2014	Other	Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Mar 3, 2014	Class II	Z-1302-2014	Other	Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Feb 7, 2014	Class II	Z-0991-2014	Process control	Tyvek packaging may be worn, causing loss of package integrity.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
7 of the 43 ancestors have a recall of any class.
1 other device also cites its predicate K042553.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

What is it indicated for?

The BioCardia Morph® Sheath Guide is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090999 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090999: Biocardia Morph Sheath Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090999

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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