510(k) · Cleared

Cleared

Safe Maxi Hollow Fiber Oxygenator, Model 016010

K013038510(k) TraditionalCleared Aug 14, 2002338-day reviewClass II21 CFR 870.4350

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

Polystan A/S · DTZ Oxygenator, Cardiopulmonary Bypass

Cleared on Aug 14, 2002 as substantially equivalent to K992559 (Jostra Bentley, 1999) after a 338-day review. Its family tree reaches back 2 generations to 1993.

Decided: Aug 14, 2002
Review: 338 days
Class: Class II
Product code: DTZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K932252 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK932252 Affinity Hollow Fiber OxygenatorAvecor Cardiovascular, Inc. · 1993
1 generation backK992559 Hollow Fiber Membrane Oygenator Quadrox Hmo 1010Jostra Bentley · 1999
This deviceK013038 Safe Maxi Hollow Fiber Oxygenator, Model 016010Polystan A/S · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K932252	Affinity Hollow Fiber Oxygenator	Avecor Cardiovascular, Inc.	1993	—
−1	K992559	Hollow Fiber Membrane Oygenator Quadrox Hmo 1010	Jostra Bentley	1999	—
0 (this device)	K013038	Safe Maxi Hollow Fiber Oxygenator, Model 016010	Polystan A/S	2002	—

FIG. 1 — Lineage of K013038, 1993–2002Source: 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 DTZ? 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 DTZ device

#1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 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
*	K992559	Hollow Fiber Membrane Oygenator Quadrox Hmo 1010 Summary page 1 …CFR - 870.4350) Predicate Device Name@): Quadrox HMO I010 HF Membrane Oxygenator - Jostra AG - 510(k) no. K992559. Device Description SAFE MAXI is a hollow fiber oxygenator with an integral venous heat exchanger. The SAF…	Jostra Bentley	1999	—

Also cleared against K992559: 3 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 9 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K992559.

How does its category compare?

All DTZ devices

DTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTZ

2in 2025

2007high 9 (2009) · low 2 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTZ

124in 2024

2007high 336 (2021) · low 28 (2013)2026

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

Recalls per year · DTZ

1in 2025

2007high 14 (2012) · low 0 (2009)2026

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

Adverse event reports per year · DTZ

976in 2025

2007high 976 (2025) · low 52 (2009)2025

MAUDE reports naming product code DTZ, 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	4	55	7	134
2008	3	88	5	105
2009	9	210	0	52
2010	2	—	1	119
2011	4	160	13	190
2012	9	90	14	215
2013	9	28	0	346
2014	5	28	2	764
2015	9	134	0	658
2016	3	62	1	443
2017	2	—	0	388
2018	3	72	2 (2)	320
2019	5	90	1	489
2020	5	93	3	442
2021	5	336	1 (1)	595
2022	2	—	6	559
2023	5	145	0	738
2024	3	124	0	535
2025	2	—	1	976
2026	3	137	0	—

What is it indicated for?

The SAFE MAXI - hollow fiber oxygenator is intended for use in an extracorporeal circuit to oxygenate and remove carbon dioxide from blood and to regulate the blood temperature during cardiopulmonary bypass procedures up to 6 hours in duration.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K013038 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013038: Safe Maxi Hollow Fiber Oxygenator, Model 016010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013038

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026