510(k) Report

510(k) · Cleared

Cleared

Pressure Infuser

K820159510(k) TraditionalCleared Apr 21, 198291-day reviewClass I21 CFR 880.5420

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

David Clark Company, Inc. · KZD Infusor, Pressure, For I.V. Bags

Cleared on Apr 21, 1982 after a 91-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
Apr 21, 1982
Review
91 days
Class
Class I
Product code
KZD
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2018: 1 descendant cleared19801990200020102020
  1. This deviceK820159 Pressure InfuserDavid Clark Company, Inc. · 1982
  2. Descendant · cites it directly · 1 of its ownK090736 Power Infuser, Model M100B-3AZOLL Medical Corporation · 2009
  3. Descendant · 2 generations on · 0 of its ownK172653 Power InfuserZOLL Medical Corporation · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K090736Power Infuser, Model M100B-3AZOLL Medical Corporation · 2009 · cites it directly1descendant
  • K172653Power InfuserZOLL Medical Corporation · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K820159Pressure InfuserDavid Clark Company, Inc.1982—
+1K090736Power Infuser, Model M100B-3AZOLL Medical Corporation2009—
+2K172653Power InfuserZOLL Medical Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201810
FIG. 1 — Lineage of K820159, 1982–2018Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KZD? 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
K090736Power Infuser, Model M100B-3AZOLL Medical Corporation20091

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, K090736 (ZOLL Medical Corporation, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KZD devices

KZD Infusor, Pressure, For I.V. Bags: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZD

FDA has decided no KZD device since 2007.

Median 510(k) review, days · KZD

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

Recalls per year · KZD

1in 2011

2008: 112009: 12011: 1
2007high 11 (2008) · low 0 (2007)2026

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

Adverse event reports per year · KZD

41in 2025

2008: 32009: 62010: 92011: 122012: 12014: 722015: 312016: 42017: 382018: 62019: 42020: 82021: 132022: 452023: 312024: 432025: 41
2007high 72 (2014) · low 0 (2007)2025

MAUDE reports naming product code KZD, 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—00
20080—113
20090—16
20100—09
20110—112
20120—01
20130—00
20140—072
20150—031
20160—04
20170—038
20180—06
20190—04
20200—08
20210—013
20220—045
20230—031
20240—043
20250—041
20260—0—

Recent decisions in KZD

The KZD category page

  • K974074Infusion Dynamics Power InfuserInfusion Dynamics, Inc. · 1998
  • K973843Msi Pressure InfusorSmith Assoc. · 1997
  • K953290Olympus Automatic Surgical Irrigation PumpOlympus America, Inc. · 1995
  • K951988PressurizerPromedic, Inc. · 1995
  • K942933Pressure Infusion CuffCirculatory Technology, Inc. · 1994

https://510kreport.com/device/K820159 · printed Nov 4, 2026

Cite this page

510(k) Report. “K820159: Pressure Infuser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K820159

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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