510(k) Report

510(k) · Decided

Decided

B. Braun IV Start Kits

K950184510(k) TraditionalDecided Mar 15, 199557-day reviewClass II21 CFR 880.5200

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

B. Braun of America, Inc. · LRS I.V. Start Kit

Cleared on Mar 15, 1995 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 15, 1995
Review
57 days
Class
Class II
Product code
LRS
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K950184Source: FDA 510(k) database · 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 LRS? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All LRS devices

LRS I.V. Start Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LRS

FDA has decided no LRS device since 2007.

Median 510(k) review, days · LRS

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

Recalls per year · LRS

1in 2025

2009: 72010: 292011: 612016: 12017: 12019: 72022: 72024: 12025: 12026 (partial year): 12, 4 Class I
2007high 61 (2011) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · LRS

34in 2025

2008: 12009: 42010: 22011: 12012: 82013: 122014: 62015: 62016: 82017: 32018: 52019: 112020: 72021: 72022: 72023: 342024: 202025: 34
2007high 34 (2023) · low 0 (2007)2025

MAUDE reports naming product code LRS, 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
20080—01
20090—74
20100—292
20110—611
20120—08
20130—012
20140—06
20150—06
20160—18
20170—13
20180—05
20190—711
20200—07
20210—07
20220—77
20230—034
20240—120
20250—134
20260—12 (4)—

More from B. Braun of America, Inc.

19 FDA decisions under this applicant name. See the company

  • K993024Celsite Implantable Port with Valved CatheterB. Braun of America, Inc. · 20001 recall
  • K983794Chemo Mini Spike PlusB. Braun of America, Inc. · 1999
  • K946170Comfort-Q Subcutaneous Injection SetsB. Braun of America, Inc. · 1995
  • K945850Braun Diacan (R) Fistula NeedlesB. Braun of America, Inc. · 1995
  • K942988Filtered Extension SetsB. Braun of America, Inc. · 199532 recalls

Recent decisions in LRS

The LRS category page

  • K050654Amsino I.V. Start KitAmsino International, Inc. · 2005
  • K001879Infusion IV SetNirvi Intl. USA · 2001
  • K963722IV Start KitGrand Medical Products · 1996
  • K951167Ems I.V. Start KitEmergency Medical Supply, Inc. · 1995
  • K944041Personal Hearing SystemResound Corp. · 1994

https://510kreport.com/device/K950184 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950184: B. Braun IV Start Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950184

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026