510(k) Report

510(k) · Cleared

Cleared

BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors

K120823510(k) TraditionalCleared Jun 15, 201288-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

Fresenius Medical Care North America, Design Cente · FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Cleared on Jun 15, 2012 as substantially equivalent to K082719 (Nikkiso CO., LTD., 2009) after an 88-day review. Its family tree reaches back 2 generations to 2001. 8 later devices descend from it.

Decided
Jun 15, 2012
Review
88 days
Class
Class II
Product code
FJK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K010264 (2001). 8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2022: 1 descendant cleared2024: 2 descendants clearedK010264 · Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set · Nipro Medical Corp. · 2001K082719 · Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P · Nikkiso CO., LTD. · 2009200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants K082719 · Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P · Nikkiso CO., LTD. · 2009K010264 · Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set · Nipro Medical Corp. · 20010
  1. Root · 2 generations backK010264 Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors…Nipro Medical Corp. · 2001
  2. 1 generation backK082719 Nikkline Blood Tubing Lines with Transducer Protectors, Models…Nikkiso CO., LTD. · 2009
  3. This deviceK120823 BVM Hemodialysis Blood Tubing Set with Attached Priming Set and…Fresenius Medical Care North America, Design Cente · 2012
  4. Descendant · cites it directly · 7 of its ownK140841 Tablo CartridgeHome Dialysis Plus · 2014
  5. Descendant · 2 generations on · 3 of its ownK193670 SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd. · 2020
  6. Descendant · 3 generations on · 2 of its ownK210661 SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd. · 2021
  7. Descendant · 2 generations on · 2 of its ownK190793 Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc. · 2019 · Recalled
  8. Descendant · 3 generations on · 1 of its ownK210782 Tablo CartridgeOutset Medical, Inc. · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014: 12019: 12020: 12021: 22022: 12024: 2
2014high 2 (2021) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all
  • K140841Tablo CartridgeHome Dialysis Plus · 2014 · cites it directly7descendants
  • K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd. · 2020 · 2 generations on3descendants
  • K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd. · 2021 · 3 generations on2descendants
  • K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc. · 2019 · 2 generations on2descendants
  • K210782Tablo CartridgeOutset Medical, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K010264Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming…Nipro Medical Corp.2001—
−1K082719Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P…Nikkiso CO., LTD.2009—
0 (this device)K120823BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer…Fresenius Medical Care North America, Design Cente2012—
+1K140841Tablo CartridgeHome Dialysis Plus2014—
+2K193670SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube SetQuanta Dialysis Technologies, Ltd.2020—
+3K210661SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood TubesetQuanta Dialysis Technologies, Ltd.2021—
+2K190793Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.20192
+3K210782Tablo CartridgeOutset Medical, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201910
202010
202120
202210
202420
FIG. 1 — Lineage of K120823, 2001–2024Source: 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
*K082719Nikkline Blood Tubing Lines with Transducer Protectors, Models AV06A-P, AVO6B-P, AV06C-P
Summary page 1
…Valve 21 CFR 876.5820 C. Legally Marketed Predicate Device (unmodified devices) Nikkline Blood Tubing Lines with Transducer Protectors (K082719) wFRESENIUS v MEDICAL CARE BVM Hemodialysis Blood Tubing Set…
Nikkiso CO., LTD.2009—

Also cleared against K082719: 2 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K140841Tablo CartridgeHome Dialysis Plus20147

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 11 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K140841 (Home Dialysis Plus, 2014) has gone furthest, with 7 descendants of its own.
  • 2 other devices also cite its predicate K082719.

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. 2012, 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 Blood Volume Monitor (BVMV) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer.

The BVMV.Hemodlialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.

Indications for use as stated in the FDA summary.

Also cleared against K082719

2 other devices cite the same predicate.

  • K231589Blood Tubing Lines for Hemodialysis AV06C-ENikkiso CO., LTD. · 2023
  • K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNikkiso CO., LTD. · 2023

More from Fresenius Medical Care North America…

5 FDA decisions under this applicant name. See the company

  • K123630Fresenius Liberty CyclerFresenius Medical Care North America, Design Cente · 20131 recall
  • K121421Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)Fresenius Medical Care North America, Design Cente · 20132 recalls
  • K120505Fresenius 2008T Hemodialysis MachineFresenius Medical Care North America, Design Cente · 20124 recalls
  • K101715Fresenius 2008T Hemodialysis Machine Model 190573Fresenius Medical Care North America, Design Cente · 20101 recall

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/K120823 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120823: BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120823

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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