510(k) Report

510(k) · Cleared

Cleared

Prefilled Syringe for Inflation of Foley Catheter

K952414510(k) TraditionalCleared Jun 23, 199531-day reviewClass II21 CFR 876.5130

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

Acacia Laboratories, Inc. · KNY Accessories, Catheter, G-U

Cleared on Jun 23, 1995 after a 31-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
Jun 23, 1995
Review
31 days
Class
Class II
Product code
KNY
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952414 Prefilled Syringe for Inflation of Foley CatheterAcacia Laboratories, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK090121 Pre-Filled Catheter Inflation SyringeAvail Medical Products, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K090121Pre-Filled Catheter Inflation SyringeAvail Medical Products, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952414Prefilled Syringe for Inflation of Foley CatheterAcacia Laboratories, Inc.1995—
+1K090121Pre-Filled Catheter Inflation SyringeAvail Medical Products, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K952414, 1995–2009Source: 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 KNY? 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 KNY device

  1. #1 K260919 Transurethral Catheter Safety Valve (TUCSV)…score 11.8 · 1 generation · 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
K090121Pre-Filled Catheter Inflation SyringeAvail Medical Products, Inc.20090

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, K090121 (Avail Medical Products, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KNY devices

KNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNY

1in 2018

2009: 12011: 12012: 12013: 22014: 32017: 12018: 12026 (partial year): 1
2007high 3 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNY

103in 2014

2014: 103 days median
2007high 103 (2014)2026

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

Recalls per year · KNY

1in 2024

2011: 12024: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KNY

3in 2025

2007: 152008: 192009: 102010: 122011: 62012: 52013: 82014: 72015: 132016: 192017: 212018: 172019: 192020: 362021: 172022: 192023: 132024: 52025: 3
2007high 36 (2020) · low 3 (2025)2025

MAUDE reports naming product code KNY, 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—015
20080—019
20091—010
20100—012
20111—16
20121—05
20132—08
2014310307
20150—013
20160—019
20171—021
20181—017
20190—019
20200—036
20210—017
20220—019
20230—013
20240—15
20250—03
20261—0—

More from Acacia Laboratories, Inc.

12 FDA decisions under this applicant name. See the company

  • K952419Sterigauze Gel DressingAcacia Laboratories, Inc. · 1995
  • K952420Sterigauze Wet DressingAcacia Laboratories, Inc. · 1995
  • K951861Stericare Wound Care GelAcacia Laboratories, Inc. · 1995
  • K951914Hydracare Absorbent Wound DressingAcacia Laboratories, Inc. · 1995
  • K950344Horizon Foley Catheterization Tray Without CatheterAcacia Laboratories, Inc. · 1995

Recent decisions in KNY

The KNY category page

  • K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical, Ltd. · 2026
  • K182144Bi-Flex EvoPromepla Sam · 2018
  • K162356Vesair Cystoscopic SheathSolace Therapeutics · 2017
  • K140441BI-Flex Ureteral Access SheathPromepla Sam · 2014
  • K140562Wijay EZ-Void External Catheter ValveLeomed, LLC · 2014

https://510kreport.com/device/K952414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952414: Prefilled Syringe for Inflation of Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952414

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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