510(k) Report

510(k) · Cleared

Cleared

Safe Maxi Venous/Cardiotomy Reservior, Model 016045

K022281510(k) TraditionalCleared Aug 6, 200222-day reviewClass II21 CFR 870.4400

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

Polystan A/S · DTN Reservoir, Blood, Cardiopulmonary Bypass

Cleared on Aug 6, 2002 as substantially equivalent to K980974 (Polystan A/S, 2000) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 1988.

Decided
Aug 6, 2002
Review
22 days
Class
Class II
Product code
DTN
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K883923 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK883923 · Cardiotomy/Venous Reservoir NO.: CVR Series · Gish Biomedical, Inc. · 19881985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K883923 · Cardiotomy/Venous Reservoir NO.: CVR Series · Gish Biomedical, Inc. · 19880
  1. Root · 1 generation backK883923 Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc. · 1988
  2. This deviceK022281 Safe Maxi Venous/Cardiotomy Reservior, Model 016045Polystan A/S · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883923Cardiotomy/Venous Reservoir NO.: CVR SeriesGish Biomedical, Inc.1988—
0 (this device)K022281Safe Maxi Venous/Cardiotomy Reservior, Model 016045Polystan A/S2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K022281, 1988–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DTN? 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 DTN device

  1. #1 K251783 Inspire HCR and HCR DUAL cardiotomy reservoirsscore 12.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K980974Safe Mini
Summary page 1
…tion line blood filter (21 CFR- 870.4270) Predicate Device Name(s): SAFE MINI oxygenator with venouskardiotomy reservoir - 51O(k) no. K980974 Gish Biomedical CardiotomyNenous Reservoir 510 (k) no. K883923 Device Description : SAFE MAXI venouskardi…
Polystan A/S2000—
*K883923Cardiotomy/Venous Reservoir NO.: CVR Series
Summary page 1
…(s): SAFE MINI oxygenator with venouskardiotomy reservoir - 51O(k) no. K980974 Gish Biomedical CardiotomyNenous Reservoir 510 (k) no. K883923 Device Description : SAFE MAXI venouskardiotomy reservoir is a hard shell reservoir with separate venous a…
Gish Biomedical, Inc.1988—

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?

  • None of the 2 ancestors has a recall.

How does its category compare?

All DTN devices

DTN Reservoir, Blood, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTN

1in 2025

2007: 22008: 12009: 72010: 12011: 22013: 42014: 32015: 22017: 22023: 12024: 22025: 1
2007high 7 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTN

38in 2014

2009: 211 days median2013: 79 days median2014: 38 days median
2007high 211 (2009) · low 38 (2014)2026

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

Recalls per year · DTN

2in 2018

2007: 12008: 12009: 12011: 12016: 12017: 12018: 2
2007high 2 (2018) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DTN

8in 2025

2007: 102008: 82009: 102010: 182011: 102012: 172013: 472014: 522015: 272016: 62017: 32018: 42019: 112020: 62021: 122022: 72023: 82024: 102025: 8
2007high 52 (2014) · low 3 (2017)2025

MAUDE reports naming product code DTN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—110
20081—18
20097211110
20101—018
20112—110
20120—017
2013479047
2014338052
20152—027
20160—16
20172—13
20180—24
20190—011
20200—06
20210—012
20220—07
20231—08
20242—010
20251—08
20260—0—

What is it indicated for?

The SAFE MAXI venouskardiotomy reservoir is intended for use with an oxygenator in an extracorporeal circuit to store venous return blood and to defoam and filter intra-thoracic suction blood prior to returning it to the extracorporeal circuit.

Indications for use as stated in the FDA summary.

More from Polystan A/S

6 FDA decisions under this applicant name. See the company

  • K023251Pediatric Arterial CannulaPolystan A/S · 20021 recall
  • K013038Safe Maxi Hollow Fiber Oxygenator, Model 016010Polystan A/S · 2002
  • K980974Safe MiniPolystan A/S · 2000
  • K953976Safe MicroPolystan A/S · 1997
  • K912082Safe IIPolystan A/S · 1991

Recent decisions in DTN

The DTN category page

  • K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
  • K241206Quantum Perfusion Hybrid SystemSpectrum Medical S.R.L. · 2024
  • K241053MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™…Medtronic Cardiac Surgery · 2024
  • K223361BMR 1900 PhisioSorin Group Italia S.R.L. · 2023
  • K170583Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceMedtronic, Inc. · 2017

https://510kreport.com/device/K022281 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022281: Safe Maxi Venous/Cardiotomy Reservior, Model 016045.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022281

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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