510(k) Report

510(k) · Decided

Decided

Impra Flex Grafts (Various Product Code Numbers)

K924360510(k) TraditionalDecided Nov 25, 199289-day reviewClass II21 CFR 870.3450

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

Impra, Inc. · DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

Cleared on Nov 25, 1992 after an 89-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
Nov 25, 1992
Review
89 days
Class
Class II
Product code
DYF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2010: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK924360 Impra Flex Grafts (Various Product Code Numbers)Impra, Inc. · 1992
  2. Descendant · cites it directly · 1 of its ownK094044 Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited · 2010
  3. Descendant · 2 generations on · 0 of its ownK252277 Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K094044Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited · 2010 · cites it directly1descendant
  • K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924360Impra Flex Grafts (Various Product Code Numbers)Impra, Inc.1992—
+1K094044Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited2010—
+2K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
202510
FIG. 1 — Lineage of K924360, 1992–2025Source: 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 DYF? 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
K094044Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited20101

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, K094044 (Tayside Flow Technologies Limited, 2010) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DYF devices

DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYF

FDA has decided no DYF device since 2007.

Median 510(k) review, days · DYF

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

Recalls per year · DYF

No recall names DYF since 2007.

Adverse event reports per year · DYF

3in 2025

2007: 52008: 42009: 22010: 62011: 92012: 22013: 162014: 72015: 122016: 352017: 182018: 62019: 52020: 72021: 52022: 92023: 82024: 62025: 3
2007high 35 (2016) · low 2 (2009)2025

MAUDE reports naming product code DYF, 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—05
20080—04
20090—02
20100—06
20110—09
20120—02
20130—016
20140—07
20150—012
20160—035
20170—018
20180—06
20190—05
20200—07
20210—05
20220—09
20230—08
20240—06
20250—03
20260—0—

More from Impra, Inc.

29 FDA decisions under this applicant name. See the company

  • K004012Impra Carboflo Eptfe Vascular GraftsImpra, Inc. · 2001
  • K004011Impra Carboflo Vascular Graft, Impra Carboflo Vascular Grafts for a-V AccessImpra, Inc. · 2001
  • K991027BI-Directional TunnelerImpra, Inc. · 1999
  • K983769Distaflo Bypass GraftImpra, Inc. · 1998
  • K983861Distaflo Bypass GraftImpra, Inc. · 19982 recalls

Recent decisions in DYF

The DYF category page

  • K004012Impra Carboflo Eptfe Vascular GraftsImpra, Inc. · 2001
  • K000504Advanta Super Soft GraftAtrium Medical Corp. · 20001 recall
  • K992958Advanta Graft (<6MM)Atrium Medical Corp. · 199915 recalls
  • K991683Ptfe Ringed Gore-Tex Vascular GraftW. L. Gore & Associates, Inc. · 1999
  • K992441Advanta GraftAtrium Medical Corp. · 19991 recall

https://510kreport.com/device/K924360 · printed Nov 5, 2026

Cite this page

510(k) Report. “K924360: Impra Flex Grafts (Various Product Code Numbers).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K924360

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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