510(k) · Cleared

Recalled · 2008

Bio-Medicus Percutaneous Cannula & Introducer Set

K884129510(k) TraditionalCleared Dec 21, 198882-day reviewClass II21 CFR 870.1250Recalls 1

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

Bio Medicus, Inc. · DQY Catheter, Percutaneous

Cleared on Dec 21, 1988 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it. It has been recalled once.

Decided: Dec 21, 1988
Review: 82 days
Class: Class II
Product code: DQY
Recalls: 1
Predicates: 0

19 later devices descend from it, 3 citing it directly.

This deviceK884129 Bio-Medicus Percutaneous Cannula & Introducer SetBio Medicus, Inc. · 1988
Descendant · cites it directly · 9 of its ownK142673 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2014
Descendant · cites it directly · 8 of its ownK052524 Bio-Medicus Multi-Stage Venous Femoral Percutaneous KitMedtronic Perfusion Systems · 2005
Descendant · 2 generations on · 6 of its ownK180453 Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2018
Descendant · cites it directly · 5 of its ownK111972 Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm…Medtronic, Inc. · 2011
Descendant · 2 generations on · 4 of its ownK120988 DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous…Medtronic, Inc. · 2012 · Recalled

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2005high 3 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 19 · See all

K142673Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2014 · cites it directly9descendants
K052524Bio-Medicus Multi-Stage Venous Femoral Percutaneous KitMedtronic Perfusion Systems · 2005 · cites it directly8descendants
K180453Bio-Medicus Adult Cannulae and IntroducerMedtronic, Inc. · 2018 · 2 generations on6descendants
K111972Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…Medtronic, Inc. · 2011 · cites it directly5descendants
K120988DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single…Medtronic, Inc. · 2012 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K884129	Bio-Medicus Percutaneous Cannula & Introducer Set	Bio Medicus, Inc.	1988	—
+1	K142673	Bio-Medicus Adult Cannulae and Introducer	Medtronic, Inc.	2014	—
+1	K052524	Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit	Medtronic Perfusion Systems	2005	—
+2	K180453	Bio-Medicus Adult Cannulae and Introducer	Medtronic, Inc.	2018	—
+1	K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia…	Medtronic, Inc.	2011	—
+2	K120988	DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula…	Medtronic, Inc.	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	1	0
2011	2	0
2012	1	0
2014	2	0
2016	1	0
2018	2	0
2021	2	0
2022	1	0
2024	2	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K884129, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQY? 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 DQY device

#1 K234115 APRO 55 Catheterscore 17.5 · 6 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (19)

See all 19

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142673	Bio-Medicus Adult Cannulae and Introducer	Medtronic, Inc.	2014	9
K052524	Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit	Medtronic Perfusion Systems	2005	8
K111972	Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity…	Medtronic, Inc.	2011	5

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 9, 2008	Not classified	Z-1929-2008	Nonconforming Material/Component	Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K142673 (Medtronic, Inc., 2014) has gone furthest, with 9 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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	16	85	6	313
2008	31	66	12	496
2009	37	73	17	819
2010	22	74	32	1,293
2011	36	71	6	1,211
2012	30	87	2	1,191
2013	32	92	36 (1)	1,352
2014	19	127	3	1,497
2015	27	118	3	2,337
2016	22	117	22 (7)	2,252
2017	26	113	8	2,489
2018	25	106	2	2,855
2019	30	111	1	2,902
2020	20	120	2	2,889
2021	18	81	2	3,006
2022	18	74	0	2,643
2023	18	114	17	3,049
2024	16	87	1	3,190
2025	21	115	1 (1)	3,056
2026	11	30	2 (1)	—

https://510kreport.com/device/K884129 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884129: Bio-Medicus Percutaneous Cannula & Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884129

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026