510(k) Report

510(k) · Cleared

Cleared

Spiral Laminar Flow Vascular Arteriovenous Graft

K094044510(k) TraditionalCleared Mar 23, 201082-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

Tayside Flow Technologies Limited · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Cleared on Mar 23, 2010 as substantially equivalent to K083169 (Tayside Flow Technologies Limited, 2009) and 5 other predicates after an 82-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.

Decided
Mar 23, 2010
Review
82 days
Class
Class II
Product code
DSY
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K983861 (1998). 10 ancestors in all, the oldest K924360 (1992). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 3 other ancestors1992: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor2025: 1 descendant clearedK983861 · Distaflo Bypass Graft · Impra, Inc. · 1998 · recalledK050049 · Dynaflo Bypass Graft · Bard Peripheral Vascular, Inc. · 2005K083169 · Eptfe Slftm Spiral Vascular Graft · Tayside Flow Technologies Limited · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K083169 · Eptfe Slftm Spiral Vascular Graft · Tayside Flow Technologies Limited · 2009K050049 · Dynaflo Bypass Graft · Bard Peripheral Vascular, Inc. · 2005K983861 · Distaflo Bypass Graft · Impra, Inc. · 1998 · recalled0
  1. Root · 3 generations backK983861 Distaflo Bypass GraftImpra, Inc. · 1998 · Recalled
  2. 2 generations backK050049 Dynaflo Bypass GraftBard Peripheral Vascular, Inc. · 2005
  3. 1 generation backK083169 Eptfe Slftm Spiral Vascular GraftTayside Flow Technologies Limited · 2009
  4. This deviceK094044 Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited · 2010
  5. Descendant · cites it directly · 0 of its ownK252277 Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K983861Distaflo Bypass GraftImpra, Inc.19982
−2K050049Dynaflo Bypass GraftBard Peripheral Vascular, Inc.2005—
−1K083169Eptfe Slftm Spiral Vascular GraftTayside Flow Technologies Limited2009—
0 (this device)K094044Spiral Laminar Flow Vascular Arteriovenous GraftTayside Flow Technologies Limited2010—
+1K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199810
199910
200530
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K094044, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSY? 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 DSY device

  1. #1 K252445 Fusion Bioline Vascular Graftscore 12.4 · 5 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? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K083169Eptfe Slftm Spiral Vascular Graft
Summary page 2
…quivalence: The Tayside Flow Technologies (TFT) Spiral Laminar FlJow TM Vascular Arteriovenous Graft is substantially equivalent to TFT SLF TM Peripheral Vascular Graft (K083169), Veryan Medical Limited SwirlGraftTm Graft (K051312/K060741), Bard IMPRA Venaflo Vascular Access Graft (K052282), Bard IMPRA Cen…
Tayside Flow Technologies Limited2009—
*K051312Swirlgraft Bypass and Vascular Access Grafts
Summary page 2
…l Laminar FlJow TM Vascular Arteriovenous Graft is substantially equivalent to TFT SLF TM Peripheral Vascular Graft (K083169), Veryan Medical Limited SwirlGraftTm Graft (K051312/K060741), Bard IMPRA Venaflo Vascular Access Graft (K052282), Bard IMPRA CenterFlext Vascular Access Graft (K924360) and Vascutek…
Veryan Medical Limited2005—
*K060741Swirlgraft Vascular Access Graft
Summary page 2
…r FlJow TM Vascular Arteriovenous Graft is substantially equivalent to TFT SLF TM Peripheral Vascular Graft (K083169), Veryan Medical Limited SwirlGraftTm Graft (K051312/K060741), Bard IMPRA Venaflo Vascular Access Graft (K052282), Bard IMPRA CenterFlext Vascular Access Graft (K924360) and Vascutek F'TFE S…
Veryan Medical Limited2006—
*K052282Venaflo II Vascular Graft
Summary page 2
…ally equivalent to TFT SLF TM Peripheral Vascular Graft (K083169), Veryan Medical Limited SwirlGraftTm Graft (K051312/K060741), Bard IMPRA Venaflo Vascular Access Graft (K052282), Bard IMPRA CenterFlext Vascular Access Graft (K924360) and Vascutek F'TFE Supported ePTFE Vascular Prostheses (K043552). Devic…
Bard Peripheral Vascular, Inc.2005—
*K924360Impra Flex Grafts (Various Product Code Numbers)
Summary page 2
…(K083169), Veryan Medical Limited SwirlGraftTm Graft (K051312/K060741), Bard IMPRA Venaflo Vascular Access Graft (K052282), Bard IMPRA CenterFlext Vascular Access Graft (K924360) and Vascutek F'TFE Supported ePTFE Vascular Prostheses (K043552). Device Description: The TIFT Spiral Lamninar FJowTM Vascular…
Impra, Inc.1992—
*K043552Vascutek Ptfe Supported Eptfe Vascular Prostheses
Summary page 2
…0741), Bard IMPRA Venaflo Vascular Access Graft (K052282), Bard IMPRA CenterFlext Vascular Access Graft (K924360) and Vascutek F'TFE Supported ePTFE Vascular Prostheses (K043552). Device Description: The TIFT Spiral Lamninar FJowTM Vascular Arteriovenous Graft is to be used as an arteriovenous conduit for…
Vascutek, Ltd.2005—

Also cleared against K083169: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited20250

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?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K252277 (Vascular Flow Technologies Limited, 2025) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K083169.

How does its category compare?

All DSY devices

DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DSY

2in 2025

2007: 12008: 12009: 52010: 42011: 12012: 42013: 52014: 22015: 12016: 12017: 32018: 12019: 12020: 12021: 22022: 22023: 22024: 52025: 22026 (partial year): 1
2007high 5 (2009) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSY

160in 2024

2009: 73 days median2010: 55 days median2012: 30 days median2013: 69 days median2017: 269 days median2024: 160 days median
2007high 269 (2017) · low 30 (2012)2026

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

Recalls per year · DSY

1in 2025

2009: 22010: 52013: 12016: 22025: 12026 (partial year): 1
2007high 5 (2010) · low 0 (2007)2026

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

Adverse event reports per year · DSY

151in 2025

2007: 1202008: 1642009: 1932010: 1872011: 1652012: 1772013: 2072014: 3522015: 4602016: 2172017: 1932018: 2002019: 2322020: 1692021: 1682022: 1552023: 1492024: 1532025: 151
2007high 460 (2015) · low 120 (2007)2025

MAUDE reports naming product code DSY, 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
20071—0120
20081—0164
20095732193
20104555187
20111—0165
20124300177
20135691207
20142—0352
20151—0460
20161—2217
201732690193
20181—0200
20191—0232
20201—0169
20212—0168
20222—0155
20232—0149
202451600153
20252—1151
20261—1—

What is it indicated for?

The Spiral Laminar FloWTM Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemnodialysis.

ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.

Indications for use as stated in the FDA summary.

Also cleared against K083169

2 other devices cite the same predicate.

  • K150389Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2015
  • K142062Spiral Flow Peripheral Vascular GraftVascular Flow Technologies, Ltd. · 2014

More from Tayside Flow Technologies Limited

2 FDA decisions under this applicant name. See the company

  • K083169Eptfe Slftm Spiral Vascular GraftTayside Flow Technologies Limited · 2009

Recent decisions in DSY

The DSY category page

  • K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLC · 2026
  • K252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies Limited · 2025
  • K241550Gelweave™ Vascular ProsthesesVascutek, Ltd. · 20251 recall
  • K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd. · 20241 recall
  • K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024

https://510kreport.com/device/K094044 · printed Nov 6, 2026

Cite this page

510(k) Report. “K094044: Spiral Laminar Flow Vascular Arteriovenous Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094044

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026