510(k) Report

510(k) · Cleared

Cleared

Medrad Twist & GO High Pressure Connector Tubing

K131517510(k) SpecialCleared Aug 2, 201366-day reviewClass II21 CFR 880.5440

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

Medrad, Inc. / Bayer Medical Care, Inc. · FPK Tubing, Fluid Delivery

Cleared on Aug 2, 2013 as substantially equivalent to K810924 (Medrad, Inc., 1981) after a 66-day review. Its family tree reaches back 1 generation to 1981.

Decided
Aug 2, 2013
Review
66 days
Class
Class II
Product code
FPK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K810924 (1981). No later device cites it as a predicate yet.

K810924 · Medrad High Pressure Conecting Tube · Medrad, Inc. · 198119801985199019952000200520102015
K810924 · Medrad High Pressure Conecting Tube · Medrad, Inc. · 19810
  1. Root · 1 generation backK810924 Medrad High Pressure Conecting TubeMedrad, Inc. · 1981
  2. This deviceK131517 Medrad Twist & GO High Pressure Connector TubingMedrad, Inc. / Bayer Medical Care, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K810924Medrad High Pressure Conecting TubeMedrad, Inc.1981—
0 (this device)K131517Medrad Twist & GO High Pressure Connector TubingMedrad, Inc. / Bayer Medical Care, Inc.2013—
FIG. 1 — Lineage of K131517, 1981–2013Source: 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), 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 FPK? 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? (1)

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
*K810924Medrad High Pressure Conecting Tube
Summary page 1
…following device: MEDRAD High Pressure Connecting Tube K810924, April 17, 1981 Device Description: The MEDRAD Twist & Go High Pressure…
Medrad, Inc.1981—

Also cleared against K810924: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K810924.

How does its category compare?

All FPK devices

FPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · FPK

1in 2013

2007: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPK

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

Recalls per year · FPK

1in 2017

2008: 92012: 142013: 12017: 1
2007high 14 (2012) · low 0 (2007)2026

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

Adverse event reports per year · FPK

30in 2025

2007: 292008: 782009: 922010: 672011: 1122012: 1072013: 292014: 312015: 152016: 122017: 152018: 92019: 102020: 42021: 82022: 72023: 152024: 82025: 30
2007high 112 (2011) · low 4 (2020)2025

MAUDE reports naming product code FPK, 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—029
20080—978
20090—092
20100—067
20110—0112
20120—14107
20131—129
20140—031
20150—015
20160—012
20170—115
20180—09
20190—010
20200—04
20210—08
20220—07
20230—015
20240—08
20250—030
20260—0—

What is it indicated for?

The Twist & Go High Pressure Connector Tubing is intended to be used in the delivery of contrast media and common flushing solutions. The device is indicated for single use only with MEDRAD injectors.

Indications for use as stated in the FDA summary.

Also cleared against K810924

1 other device cites the same predicate.

  • K071196Disposable High Pressure Injection Lines with and Without Rotating AdaptersCoeur, Inc. · 2007

More from Medrad, Inc. / Bayer Medical Care, Inc.

2 FDA decisions under this applicant name. See the company

  • K132928Medrad Mark 7 Arterion Injection System / Syringe, Twist & GO SyringeMedrad, Inc. / Bayer Medical Care, Inc. · 20142 recalls

Recent decisions in FPK

The FPK category page

  • K063114Disposable Transfer Sets with and Without Swabbable Valves and/or Check ValvesCoeur, Inc. · 2007
  • K063239Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526Hospira, Inc. · 20067 recalls
  • K052431Medtronic Minimed Leapfrog II Infusion Set, Models MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic Minimed · 2005
  • K041178Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
  • K031808Medrad Swabbable Valve Transfer SetMedrad, Inc. · 2003

https://510kreport.com/device/K131517 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131517: Medrad Twist & GO High Pressure Connector Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131517

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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