510(k) Report

510(k) · Cleared

Cleared

Disposable Wound Measure Guide, Plastic, Protector, Wound, Plastic

K951064510(k) TraditionalCleared May 19, 199572-day reviewClass I21 CFR 878.4800

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

S-E Sales & Distribution, Inc. · FTY Tape, Measuring, Rulers And Calipers

Cleared on May 19, 1995 after a 72-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 19, 1995
Review
72 days
Class
Class I
Product code
FTY
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 K951064Source: 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 FTY? 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 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 FTY devices

FTY Tape, Measuring, Rulers And Calipers: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTY

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTY

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

Recalls per year · FTY

4in 2010

2010: 4
2007high 4 (2010) · low 0 (2007)2026

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

Adverse event reports per year · FTY

9in 2025

2009: 22011: 22012: 12013: 32014: 22015: 32017: 52018: 22019: 112020: 1122021: 1612022: 932023: 92024: 122025: 9
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code FTY, 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—00
20090—02
20100—40
20110—02
20120—01
20130—03
20140—02
20150—03
20161—00
20170—05
20180—02
20190—011
20200—0112
20210—0161
20220—093
20230—09
20240—012
20250—09
20260—0—

Recent decisions in FTY

The FTY category page

  • K160501Noxilizer Surgical RulerNoxilizer, Inc. · 2016
  • K934930Olympic Auto-LengthOlympic Medical Corp. · 1993
  • K932112Olympic Infa-LengthOlympic Medical Corp. · 1993
  • K883485Stryker Pressure Monitor SystemStryker Corp. · 1988
  • K880441Pediatric Airway Measurement System & P.a.M.S.Plane Iii, Inc. · 1988

https://510kreport.com/device/K951064 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951064: Disposable Wound Measure Guide, Plastic, Protector, Wound, Plastic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951064

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