510(k) Report

510(k) · Cleared

Cleared

Nikkiso NK Pump

K920077510(k) TraditionalCleared Sep 29, 1993630-day reviewClass II21 CFR 870.4430

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

International Medical Products, Inc. · DWD Suction Control, Intracardiac, Cardiopulmonary Bypass

Cleared on Sep 29, 1993 after a 630-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Sep 29, 1993
Review
630 days
Class
Class II
Product code
DWD
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2002: 1 descendant cleared1990200020102020
  1. This deviceK920077 Nikkiso NK PumpInternational Medical Products, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK972740 Himex Centriflow Centrifugal Perfusion Pump System (CFK01)Himex Production Corp. · 1998
  3. Descendant · 2 generations on · 0 of its ownK020571 Stockert Centrifugal Pump ConsoleStockert Instrumente GmbH · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K972740Himex Centriflow Centrifugal Perfusion Pump System (CFK01)Himex Production Corp. · 1998 · cites it directly1descendant
  • K020571Stockert Centrifugal Pump ConsoleStockert Instrumente GmbH · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920077Nikkiso NK PumpInternational Medical Products, Inc.1993—
+1K972740Himex Centriflow Centrifugal Perfusion Pump System (CFK01)Himex Production Corp.1998—
+2K020571Stockert Centrifugal Pump ConsoleStockert Instrumente GmbH2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
FIG. 1 — Lineage of K920077, 1993–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 DWD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972740Himex Centriflow Centrifugal Perfusion Pump System (CFK01)Himex Production Corp.19981

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?

  • Of its descendants, K972740 (Himex Production Corp., 1998) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DWD devices

DWD Suction Control, Intracardiac, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWD

FDA has decided no DWD device since 2007.

Median 510(k) review, days · DWD

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

Recalls per year · DWD

No recall names DWD since 2007.

Adverse event reports per year · DWD

1in 2024

2007: 12008: 22009: 12010: 12011: 12012: 12013: 102014: 72015: 382016: 62017: 122018: 82019: 132020: 22022: 12023: 12024: 1
2007high 38 (2015) · low 0 (2021)2025

MAUDE reports naming product code DWD, 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—01
20080—02
20090—01
20100—01
20110—01
20120—01
20130—010
20140—07
20150—038
20160—06
20170—012
20180—08
20190—013
20200—02
20210—00
20220—01
20230—01
20240—01
20250—00
20260—0—

More from International Medical Products, Inc.

9 FDA decisions under this applicant name. See the company

  • K981003Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate MixesInternational Medical Products, Inc. · 19983 recalls
  • K973253Rockwell Medical Supply, LLC. Concentrate Solutions for Acetate DialysateInternational Medical Products, Inc. · 1997
  • K971053Rockwell Medical Supply,LLC. Bicarbonate Solution Concentrates for Bicarbonate DialysisInternational Medical Products, Inc. · 1997
  • K923942Rhombo Medical Rhombo-FillInternational Medical Products, Inc. · 1993
  • K900755Digital Cuff PV GaugeInternational Medical Products, Inc. · 1990

Recent decisions in DWD

The DWD category page

  • K992657Ibc VRV, Model 1350International Biophysics Corp. · 2000
  • K915481B-D Ultra-Vue Procedure Needle W/ Chiba Type PointBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
  • K915482B-D Ultra-Vue Procedure Needle W/ Westcott Type PTBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
  • K915480B-D Ultra-Vue Procedure Needle W/ Spinal Type PT.Bd Becton Dickinson Vacutainer Systems Preanalytic · 1992
  • K905311Duraflo II Heparin Treated Suction Wands Var. Mod.Baxter Bentley Laboratories, Inc. · 1991

https://510kreport.com/device/K920077 · printed Nov 6, 2026

Cite this page

510(k) Report. “K920077: Nikkiso NK Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920077

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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