510(k) Report

510(k) · Cleared

Recalled · 2005

Critiflo & Critiflo Dome

K791844510(k) TraditionalCleared Oct 2, 197913-day reviewClass II21 CFR 870.1210Recalls 7

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

Gould, Inc. · KRA Catheter, Continuous Flush

Cleared on Oct 2, 1979 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 7 times.

Decided
Oct 2, 1979
Review
13 days
Class
Class II
Product code
KRA
Recalls
7
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K791844Source: FDA 510(k) database · 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 KRA? 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 KRA device

  1. #1 K253509 TriSalus TriNav Advance Infusion Systemscore 14.5 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 1, 2005Not classifiedZ-0069-06OtherDevice could permit an over-infusion of IV solutions during pressure monitoring procedures.
Jul 1, 2005Not classifiedZ-0073-06OtherDevice could permit an over-infusion of IV solutions during pressure monitoring procedures.
Jul 1, 2005Not classifiedZ-0074-06OtherDevice could permit an over-infusion of IV solutions during pressure monitoring procedures.
Jul 1, 2005Not classifiedZ-0075-06OtherDevice could permit an over-infusion of IV solutions during pressure monitoring procedures.
Jul 1, 2005Not classifiedZ-0070-06OtherDevice could permit an over-infusion of IV solutions during pressure monitoring procedures.
Jul 1, 2005Not classifiedZ-0071-06OtherDevice could permit an over-infusion of IV solutions during pressure monitoring procedures.
Jul 1, 2005Not classifiedZ-0072-06OtherDevice could permit an over-infusion of IV solutions during pressure monitoring procedures.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KRA devices

KRA Catheter, Continuous Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRA

1in 2025

2007: 52008: 72009: 52010: 22011: 22012: 32013: 32014: 42016: 82017: 42018: 42019: 42020: 62021: 62022: 62023: 72025: 12026 (partial year): 5
2007high 8 (2016) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KRA

63in 2023

2007: 44 days median2008: 144 days median2009: 69 days median2012: 29 days median2013: 126 days median2014: 61 days median2016: 122 days median2017: 166 days median2018: 178 days median2019: 133 days median2020: 29 days median2021: 108 days median2022: 228 days median2023: 63 days median2026 (partial year): 268 days median
2007high 268 (2026) · low 29 (2012)2026

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

Recalls per year · KRA

41so far in 2026, the most since 2007

2007: 22008: 62009: 82010: 262011: 32012: 32013: 22014: 3, 2 Class I2015: 12016: 3, 1 Class I2019: 4, 4 Class I2020: 12023: 22026 (partial year): 41
2007high 41 (2026) · low 0 (2017)2026

Class I (7 since 2007) Class II/III not classified

Adverse event reports per year · KRA

980in 2025

2007: 1182008: 1172009: 1872010: 3552011: 2392012: 2172013: 2092014: 2762015: 3392016: 4182017: 5382018: 4342019: 4182020: 3812021: 4402022: 5432023: 8292024: 9422025: 980
2007high 980 (2025) · low 117 (2008)2025

MAUDE reports naming product code KRA, 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
20075442118
200871446117
20095698187
20102—26355
20112—3239
20123293217
201331262209
20144613 (2)276
20150—1339
201681223 (1)418
201741660538
201841780434
201941334 (4)418
20206291381
202161080440
202262280543
20237632829
20240—0942
20251—0980
2026526841—

More from Gould, Inc.

31 FDA decisions under this applicant name. See the company

  • K911935Cardiac Electrophysical Lead Selector, ModifiedGould, Inc. · 1991
  • K861092Model SP1465 Cardiac Output ComputerGould, Inc. · 1986
  • K860805Pressure Monitor Cath Models SP5325,SP5327,SP5337Gould, Inc. · 1986
  • K855145Model:TA-Rose Resonant Overshoot EliminatorGould, Inc. · 1986
  • K854403Model 2120 SpiroscreenGould, Inc. · 1986

Recent decisions in KRA

The KRA category page

  • K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences · 2026
  • K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB · 2026
  • K261610Verge™ MicrocatheterInstylla, Inc. · 2026
  • K260771TruSelect™ 2.6 MicrocatheterBoston Scientific Corporation · 2026
  • K250794InVera Infusion DeviceInvera Medical · 2026

https://510kreport.com/device/K791844 · printed Nov 4, 2026

Cite this page

510(k) Report. “K791844: Critiflo & Critiflo Dome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K791844

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026