510(k) Report

510(k) · Cleared

Cleared

Ivac (R) Volumetric Controller - Model 262

K884307510(k) TraditionalCleared Nov 1, 198819-day reviewClass II21 CFR 880.5725

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

Y · LDR Controller, Infusion, Intravascular, Electronic

Cleared on Nov 1, 1988 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Nov 1, 1988
Review
19 days
Class
Class II
Product code
LDR
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK884307 Ivac (R) Volumetric Controller - Model 262Y · 1988
  2. Descendant · cites it directly · 0 of its ownK971826 Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500Alexander Mfg. Co. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K971826Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500Alexander Mfg. Co. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884307Ivac (R) Volumetric Controller - Model 262Y1988—
+1K971826Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500Alexander Mfg. Co.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K884307, 1988–1997Source: 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 LDR? 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 LDR device

  1. #1 K232316 DEKA Infusion System, DEKA Administration Setscore 10.5 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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? (1)

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

NumberDeviceApplicantDecidedDescendants
K971826Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500Alexander Mfg. Co.19970

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, K971826 (Alexander Mfg. Co., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LDR devices

LDR Controller, Infusion, Intravascular, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LDR

2in 2024

2016: 12024: 2
2007high 2 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LDR

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

Recalls per year · LDR

1in 2017

2011: 42017: 1
2007high 4 (2011) · low 0 (2007)2026

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

Adverse event reports per year · LDR

3in 2023

2011: 12013: 12017: 22018: 222019: 12023: 3
2007high 22 (2018) · low 0 (2007)2025

MAUDE reports naming product code LDR, 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—00
20090—00
20100—00
20110—41
20120—00
20130—01
20140—00
20150—00
20161—00
20170—12
20180—022
20190—01
20200—00
20210—00
20220—00
20230—03
20242—00
20250—00
20260—0—

More from Y

78 FDA decisions under this applicant name. See the company

  • K955846Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount ThermometerY · 1996
  • K960280Ivac Needle Free Valve Administration SetsY · 19967 recalls
  • K953225Ivac Ball Valce Admin. SetsY · 1995
  • K934095Ivac Vented Syringe Adapter Administration SetsY · 1994
  • K940897Ivac Needleless Infection Valve Administration SetY · 1994

Recent decisions in LDR

The LDR category page

  • K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development Corporation · 2024
  • K232316DEKA Infusion System, DEKA Administration SetDeka Research and Development · 2024
  • K153760Volumetric Infusion ControllerDEKA Research & Development · 2016
  • K963136Pacer Model 100 Infusion ControllerHealth Watch, Inc. · 1997
  • K971865Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500-3PAlexander Mfg. Co. · 1997

https://510kreport.com/device/K884307 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884307: Ivac (R) Volumetric Controller - Model 262.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884307

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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