510(k) Report

510(k) · Cleared

Cleared

Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set

K001465510(k) TraditionalCleared Dec 5, 2000209-day reviewClass II21 CFR 876.5820

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

Nipro Medical Corp. · FIB Protector, Transducer, Dialysis

Cleared on Dec 5, 2000 after a 209-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Dec 5, 2000
Review
209 days
Class
Class II
Product code
FIB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK001465 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2000
  2. Descendant · cites it directly · 0 of its ownK013634 Bioteque 3 in 1 Hemodialysis Blood Tubing PackBioteque Corp. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K013634Bioteque 3 in 1 Hemodialysis Blood Tubing PackBioteque Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001465Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming…Nipro Medical Corp.2000—
+1K013634Bioteque 3 in 1 Hemodialysis Blood Tubing PackBioteque Corp.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K001465, 2000–2002Source: 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 FIB? 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 FIB device

  1. #1 K240164 NovaLine SP-C35 Transducer Protector (956007)score 8.2 · 3 generations · no Class I recall
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
K013634Bioteque 3 in 1 Hemodialysis Blood Tubing PackBioteque Corp.20020

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, K013634 (Bioteque Corp., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FIB devices

FIB Protector, Transducer, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FIB

1in 2024

2008: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FIB

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

Recalls per year · FIB

No recall names FIB since 2007.

Adverse event reports per year · FIB

2in 2017

2014: 12017: 2
2007high 2 (2017) · low 0 (2007)2025

MAUDE reports naming product code FIB, 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—00
20081—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—00
20160—00
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20241—00
20250—00
20260—0—

More from Nipro Medical Corp.

27 FDA decisions under this applicant name. See the company

  • K093985Nipro Safetouch Locktail Safety Fistula NeedleNipro Medical Corp. · 2010
  • K081210Nipro Safetouch Huber Infustion SetNipro Medical Corp. · 20081 recall
  • K072024Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693Nipro Medical Corp. · 20071 recall
  • K063368Nipro Biohole NeedleNipro Medical Corp. · 2007
  • K063721Nipro Safetouch II GammaNipro Medical Corp. · 2007

Recent decisions in FIB

The FIB category page

  • K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2024
  • K072988Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation · 2008
  • K001971Hemodialysis Tubing SetsOfi Biomedica S.P.A. · 2001
  • K010264Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetNipro Medical Corp. · 2001
  • K003445Fresenius Viral Blocking Transducer Protector for Hemodialysis, Model 04-9500-2Fresenius Medical Care North America · 2000

https://510kreport.com/device/K001465 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001465: Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001465

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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