510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693

K072024510(k) SpecialCleared Oct 4, 200772-day reviewClass II21 CFR 876.5820Recalls 1

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

Nipro Medical Corp. · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Cleared on Oct 4, 2007 as substantially equivalent to K010264 (Nipro Medical Corp., 2001) after a 72-day review. Its family tree reaches back 1 generation to 2001. 16 later devices descend from it. It has been recalled once.

Decided
Oct 4, 2007
Review
72 days
Class
Class II
Product code
FJK
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K010264 (2001). 16 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2008: 1 descendant cleared2024: 3 descendants cleared2022: 1 descendant cleared2021: 2 descendants cleared2026: 2 descendants cleared2025: 2 descendants clearedK010264 · Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set · Nipro Medical Corp. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K010264 · Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set · Nipro Medical Corp. · 20010
  1. Root · 1 generation backK010264 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2001
  2. This deviceK072024 Nipro Blood Tubing Set with Transducer Protector and Priming Set…Nipro Medical Corp. · 2007
  3. Descendant · cites it directly · 5 of its ownK112314 Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220…Nephros, Inc. · 2012
  4. Descendant · cites it directly · 4 of its ownK161582 DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2017
  5. Descendant · 2 generations on · 2 of its ownK231534 5008X Hemodialysis SystemFresenius Medical Care · 2024 · Recalled
  6. Descendant · 2 generations on · 2 of its ownK201866 NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2021
  7. Descendant · 3 generations on · 1 of its ownK243505 5008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · Recalled

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2008: 12012: 22016: 12017: 12018: 12021: 22022: 12024: 32025: 22026: 2
2008high 3 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 16 · See all
  • K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc. · 2012 · cites it directly5descendants
  • K161582DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2017 · cites it directly4descendants
  • K2315345008X Hemodialysis SystemFresenius Medical Care · 2024 · 2 generations on2descendants
  • K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd. · 2021 · 2 generations on2descendants
  • K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC · 2025 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010264Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming…Nipro Medical Corp.2001—
0 (this device)K072024Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model…Nipro Medical Corp.2007—
+1K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.2012—
+1K161582DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.2017—
+2K2315345008X Hemodialysis SystemFresenius Medical Care20241
+2K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.2021—
+3K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC20256

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201220
201610
201710
201810
202120
202210
202430
202520
202620
FIG. 1 — Lineage of K072024, 2001–2026Source: 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 FJK? 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 FJK device

  1. #1 K252423 NovaLine Tubing Set for Hemodialysis (BL 124)score 12.2 · 4 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? (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
*K010264Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
Summary page 1
…Panel: 78 Product Code: FJK Product Code: FIB 807.92(a)(3) Legally marketed substantial equivalent device: K(010264 - NIPRO Set Blood Tubing Set with transducer protector and priming set. 807.92(a)(4) Descriptio…
Nipro Medical Corp.2001—

Also cleared against K010264: 1 other device →

What descends from it? (16)

See all 16

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112314Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 HemodiafilterNephros, Inc.20125
K161582DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.20174
K072988Nipro Transducer Protector TP-Sure, Model Tpsure+1Nipro Medical Corporation20081
K171952Dimesol Tubing Sets for HemodialysisDimesol, Inc.20180
K150304Oxyless Blood Tubing SetOxyless, Ltd.20160
K112628Nipro Blood Tubing Set with Transducer Protector and Priming SetNipro Medical Corporation20120

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 19, 2017Class IIZ-1876-2018Process controlThere is a possibility of the heparin line is occluded.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K112314 (Nephros, Inc., 2012) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K010264.

How does its category compare?

All FJK devices

FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FJK

1in 2025

2007: 42008: 12009: 12010: 12012: 22014: 12016: 12017: 12018: 12021: 32023: 12024: 12025: 12026 (partial year): 2
2007high 4 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FJK

255in 2021

2007: 116 days median2021: 255 days median
2007high 255 (2021) · low 116 (2007)2026

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

Recalls per year · FJK

1in 2025

2007: 22008: 22010: 22015: 12020: 12025: 1, 1 Class I2026 (partial year): 1
2007high 2 (2007) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FJK

1,487in 2025

2007: 1352008: 862009: 762010: 1302011: 2432012: 352013: 1142014: 1162015: 1262016: 1392017: 1312018: 1192019: 1852020: 1902021: 1882022: 3622023: 5852024: 4172025: 1,487
2007high 1,487 (2025) · low 35 (2012)2025

MAUDE reports naming product code FJK, 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
200741162135
20081—286
20091—076
20101—2130
20110—0243
20122—035
20130—0114
20141—0116
20150—1126
20161—0139
20171—0131
20181—0119
20190—0185
20200—1190
202132550188
20220—0362
20231—0585
20241—0417
20251—1 (1)1,487
20262—1—

What is it indicated for?

The Nipro® Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient's blood during Hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

Indications for use as stated in the FDA summary.

Also cleared against K010264

1 other device cites the same predicate.

  • K082719Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-PNikkiso CO., LTD. · 2009

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
  • K063368Nipro Biohole NeedleNipro Medical Corp. · 2007
  • K063721Nipro Safetouch II GammaNipro Medical Corp. · 2007
  • K052474Nipro Hypodermic NeedleNipro Medical Corp. · 2005

Recent decisions in FJK

The FJK category page

  • K252423NovaLine Tubing Set for Hemodialysis (BL 124)Bain Medical Equipment (Guangzhou) Co., Ltd. · 2026
  • K251341VITAL Tubing Sets for HemodialysisVital Healthcare Sdn. Bhd. · 2026
  • K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd. · 2025
  • K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )Diality, Inc. · 2024
  • K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC · 20231 recall

https://510kreport.com/device/K072024 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072024: Nipro Blood Tubing Set with Transducer Protector and Priming Set, Model A201-A219, V801-V806, 5M9634, 5M9693.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072024

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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