510(k) Report

510(k) · Cleared

Cleared

Enguard PHX Cardioplegia Heat Exchanger

K991137510(k) TraditionalCleared Jun 8, 2000430-day reviewClass II21 CFR 870.4240

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

Minntech Corp. · DTR Heat-Exchanger, Cardiopulmonary Bypass

Cleared on Jun 8, 2000 as substantially equivalent to K960755 (Medtronic Cardiac Surgery, Medtronic, Inc., 1996) and 2 other predicates after a 430-day review. Its family tree reaches back 2 generations to 1990.

Decided
Jun 8, 2000
Review
430 days
Class
Class II
Product code
DTR
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K896807 (1990). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 2 other ancestors1990: 1 other ancestor1995: 1 other ancestorK896807 · SPBC Series Single Pass Blood Cardioplegia System · Gish Biomedical, Inc. · 1990K960755 · Cardiotherm Blood Cardioplegia Systems · Medtronic Cardiac Surgery, Medtronic, Inc. · 19961990199219941996199820002002
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K960755 · Cardiotherm Blood Cardioplegia Systems · Medtronic Cardiac Surgery, Medtronic, Inc. · 1996K896807 · SPBC Series Single Pass Blood Cardioplegia System · Gish Biomedical, Inc. · 19900
  1. Root · 2 generations backK896807 SPBC Series Single Pass Blood Cardioplegia SystemGish Biomedical, Inc. · 1990
  2. 1 generation backK960755 Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc. · 1996
  3. This deviceK991137 Enguard PHX Cardioplegia Heat ExchangerMinntech Corp. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K896807SPBC Series Single Pass Blood Cardioplegia SystemGish Biomedical, Inc.1990—
−1K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc.1996—
0 (this device)K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199320
199510
FIG. 1 — Lineage of K991137, 1990–2000Source: 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 DTR? 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 DTR device

  1. #1 K252541 Quantum PureFlow Standard Heat Exchanger…score 13.4 · 9 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K960755Cardiotherm Blood Cardioplegia Systems
Summary page 2
…re intended to heat or cool and facilitate delivery of a cardioplegia/blood solution. The Medtronic Corporation’s CardioTherm™ Blood Cardioplegia System (K960755), Sorin Biomedical Vanguard™ BCD Advanced Blood Cardioplegia System (K925369) and the Avecor Cardiovascular’s MyoTherm Cardiopleg…
Medtronic Cardiac Surgery, Medtronic, Inc.1996—
*K925369BCD Advanced Blood Carioplegia Systems
Summary page 2
…ioplegia/blood solution. The Medtronic Corporation’s CardioTherm™ Blood Cardioplegia System (K960755), Sorin Biomedical Vanguard™ BCD Advanced Blood Cardioplegia System (K925369) and the Avecor Cardiovascular’s MyoTherm Cardioplegia Delivery System (K904171) are all substantially equivalent to the EnGuard.…
Sorin Biomedica, Fiat, USA, Inc.1993—
*K904171Scimed Cardiotherm Cardioplegia Delivery System
Summary page 2
…egia System (K960755), Sorin Biomedical Vanguard™ BCD Advanced Blood Cardioplegia System (K925369) and the Avecor Cardiovascular’s MyoTherm Cardioplegia Delivery System (K904171) are all substantially equivalent to the EnGuard. Summary 4.1 Minntech Corporation has performed functional testing to show the…
Scimed1990—

Also cleared against K960755: 2 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 10 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
  • None of the 6 ancestors has a recall.
  • 2 other devices also cite its predicate K960755.

How does its category compare?

All DTR devices

DTR Heat-Exchanger, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTR

2in 2025

2008: 12009: 22017: 22018: 12020: 22022: 22023: 12024: 12025: 22026 (partial year): 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTR

Too few DTR 510(k)s in any year since 2007 to give a median.

Recalls per year · DTR

1in 2015

2010: 242011: 32015: 12026 (partial year): 2
2007high 24 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DTR

44in 2025

2007: 22008: 12010: 432011: 672012: 162013: 272014: 662015: 962016: 602017: 692018: 752019: 352020: 332021: 112022: 232023: 182024: 82025: 44
2007high 96 (2015) · low 0 (2009)2025

MAUDE reports naming product code DTR, 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
20070—02
20081—01
20092—00
20100—2443
20110—367
20120—016
20130—027
20140—066
20150—196
20160—060
20172—069
20181—075
20190—035
20202—033
20210—011
20222—023
20231—018
20241—08
20252—044
20261—2—

What is it indicated for?

The Minntech Corporation’s EnGuard™ Cardioplegia Heat Exchanger is used to cool or

warm cardioplegia solution prior to delivery to the patient through connected tubing sets

which provide various ratios of cardioplegia solution to blood, depending upon the tubing

set chosen.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K960755

2 other devices cite the same predicate.

  • K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc. · 1998
  • K973475Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr Series)Medtronic Vascular · 1997

More from Minntech Corp.

33 FDA decisions under this applicant name. See the company

  • K120306Rapicide Opa-28Minntech Corp. · 2012
  • K092387Medivators DSD Edge Endoscope Reprocessing SystemMinntech Corp. · 20101 recall
  • K071298HF Junior HemofilterMinntech Corp. · 2007
  • K050952HPH Junior High Performance HemoconcentratorMinntech Corp. · 2006
  • K033505Renaclean SH Dialyzer Cleaning SystemMinntech Corp. · 2004

Recent decisions in DTR

The DTR category page

  • K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L. · 2026
  • K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical, Ltd. · 2025
  • K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia…Sorin Group Italia S.R.L. · 2025
  • K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery…Medtronic · 2024
  • K223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L. · 20232 recalls

https://510kreport.com/device/K991137 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991137: Enguard PHX Cardioplegia Heat Exchanger.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991137

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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