510(k) Report

510(k) · Cleared

Recalled · 2009

Infusion Pump & IV Sets #4000

K832755510(k) TraditionalCleared Nov 3, 198379-day reviewClass II21 CFR 880.5725Recalls 16

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

Omni-Glow, Inc. · FRN Pump, Infusion

Cleared on Nov 3, 1983 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 16 times.

Decided
Nov 3, 1983
Review
79 days
Class
Class II
Product code
FRN
Recalls
16
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared19801990200020102020
  1. This deviceK832755 Infusion Pump & IV Sets #4000Omni-Glow, Inc. · 1983
  2. Descendant · cites it directly · 0 of its ownK033576 Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient…Abbott Laboratories · 2003 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible…Abbott Laboratories · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K832755Infusion Pump & IV Sets #4000Omni-Glow, Inc.1983—
+1K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line…Abbott Laboratories20036

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K832755, 1983–2003Source: 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 FRN? 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 FRN device

  1. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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?

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
K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible…Abbott Laboratories20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 24, 2009Not classifiedZ-1356-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1353-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1352-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1354-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1355-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1358-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1357-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1341-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Nov 24, 2009Not classifiedZ-1351-2010Component design/selectionReports of difficulty in adjusting the flow rate, which could result in flow rate variances.
Jan 9, 2006Not classifiedZ-0505-06OtherThe I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market.
Jun 9, 2003Not classifiedZ-0955-03OtherThe drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
Jun 9, 2003Not classifiedZ-0958-03OtherThe drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
Jun 9, 2003Not classifiedZ-0959-03OtherThe drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
Jun 9, 2003Not classifiedZ-0957-03OtherThe drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
May 13, 2003Not classifiedZ-0936-03OtherThe I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL
May 13, 2003Not classifiedZ-0915-03OtherIV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

The 5 latest of 16 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033576 (Abbott Laboratories, 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

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

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, 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
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

Recent decisions in FRN

The FRN category page

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https://510kreport.com/device/K832755 · printed Nov 5, 2026

Cite this page

510(k) Report. “K832755: Infusion Pump & IV Sets #4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K832755

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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