510(k) Report

510(k) · Cleared

Cleared

Button Lubricator

K951713510(k) TraditionalCleared Apr 25, 199511-day reviewClass II21 CFR 876.1500

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

Fibertech Instruments, Inc. · FHX Jelly, Lubricating, For Transurethral Surgical Instrument

Cleared on Apr 25, 1995 after an 11-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 25, 1995
Review
11 days
Class
Class II
Product code
FHX
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K951713Source: 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 FHX devices

FHX Jelly, Lubricating, For Transurethral Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FHX

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FHX

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

Recalls per year · FHX

No recall names FHX since 2007.

Adverse event reports per year · FHX

1in 2019

2010: 12011: 32019: 1
2007high 3 (2011) · low 0 (2007)2025

MAUDE reports naming product code FHX, 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
20081—00
20090—00
20100—01
20110—03
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Fibertech Instruments, Inc.

2 FDA decisions under this applicant name. See the company

  • K940780ScopejockeyFibertech Instruments, Inc. · 1994

Recent decisions in FHX

The FHX category page

  • K081990Lubricano Sterile GelFarco Pharma GmbH · 2008
  • K935548Cathejell S Sterile Lubricating JellyPharmazeutische Fabrik Montavit GmbH · 1994
  • K912132Operand Lubricating JellyGeneral Medical Co. · 1991
  • K780386K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1978
  • K771364Lube JelTravenol Laboratories, S.A. · 1977

https://510kreport.com/device/K951713 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951713: Button Lubricator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951713

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