510(k) Report

510(k) · Cleared

Cleared

Nipro Disposable Stopcocks, Models 3W-RC. NCN-3, 3W-R, 3W-L

K041779510(k) TraditionalCleared Sep 21, 200482-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

Nipro Medical Corp. · FMG Stopcock, I.V. Set

Cleared on Sep 21, 2004 as substantially equivalent to K911415 (B. Braun of America, Inc., 1991) after an 82-day review. Its family tree reaches back 1 generation to 1991.

Decided
Sep 21, 2004
Review
82 days
Class
Class II
Product code
FMG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K911415 (1991). No later device cites it as a predicate yet.

K911415 · Trumpet Valve · B. Braun of America, Inc. · 19911990199520002005
K911415 · Trumpet Valve · B. Braun of America, Inc. · 19910
  1. Root · 1 generation backK911415 Trumpet ValveB. Braun of America, Inc. · 1991
  2. This deviceK041779 Nipro Disposable Stopcocks, Models 3W-RC. NCN-3, 3W-R, 3W-LNipro Medical Corp. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911415Trumpet ValveB. Braun of America, Inc.1991—
0 (this device)K041779Nipro Disposable Stopcocks, Models 3W-RC. NCN-3, 3W-R, 3W-LNipro Medical Corp.2004—
FIG. 1 — Lineage of K041779, 1991–2004Source: 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 FMG? 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 FMG device

  1. #1 K242255 Qitexio® 4-Way Stopcock (QIT014)score 10.5 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K911415Trumpet Valve
Summary page 1
…Stopcocks, LV.scts (880.5440) 807.92 (a)(3) Legally Marketed Substantially Equivalent Device: B. Braun Medical inc.3-way Stopcocks (K911415) 807.92 (a)(4) Description of Device: The subject devices can be classified as stopcocks as describ…
B. Braun of America, Inc.1991—

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.

How does its category compare?

All FMG devices

FMG Stopcock, I.V. Set: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMG

1in 2025

2007: 22008: 22009: 22013: 22014: 12018: 12019: 22022: 22023: 22025: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMG

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

Recalls per year · FMG

33in 2025

2007: 52008: 42010: 22011: 82016: 12017: 22018: 32020: 52025: 33, 1 Class I2026 (partial year): 3
2007high 33 (2025) · low 0 (2009)2026

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

Adverse event reports per year · FMG

868in 2025

2007: 262008: 482009: 272010: 1312011: 952012: 932013: 1172014: 1052015: 962016: 1482017: 1142018: 1642019: 4002020: 2842021: 2452022: 2802023: 6892024: 9352025: 868
2007high 935 (2024) · low 26 (2007)2025

MAUDE reports naming product code FMG, 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
20072—526
20082—448
20092—027
20100—2131
20110—895
20120—093
20132—0117
20141—0105
20150—096
20160—1148
20170—2114
20181—3164
20192—0400
20200—5284
20210—0245
20222—0280
20232—0689
20240—0935
20251—33 (1)868
20260—3—

What is it indicated for?

The Nipro Disposable Stopcocks are intended for use to change the direction of flow of fluids through a tubing set.

Indications for use as stated in the FDA summary.

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 FMG

The FMG category page

  • K242255Qitexio® 4-Way Stopcock (QIT014)Medex · 2025
  • K223499Three Way Stop CockM/S Romsons International · 2023
  • K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation · 2023
  • K211204SafePort (TM) Manifold (or Stopcock)Elcam Medical Acal · 2022
  • K210516Clicky CrossYomura Technologies, Inc. · 2022

https://510kreport.com/device/K041779 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041779: Nipro Disposable Stopcocks, Models 3W-RC. NCN-3, 3W-R, 3W-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041779

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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