510(k) Report

510(k) · Cleared

Cleared

Tape Measure

K790089510(k) TraditionalCleared Mar 6, 197948-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

Pfizer, Inc. · FTY Tape, Measuring, Rulers And Calipers

Cleared on Mar 6, 1979 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 6, 1979
Review
48 days
Class
Class I
Product code
FTY
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2019: 1 descendant cleared19801990200020102020
  1. This deviceK790089 Tape MeasurePfizer, Inc. · 1979
  2. Descendant · cites it directly · 1 of its ownK142469 2D Mercy TAPE & 3D Mercy TAPEChildren'S Mercy Hospital · 2015
  3. Descendant · 2 generations on · 0 of its ownK191174 Mercy babyTAPEChildren'S Mercy Hospital · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K1424692D Mercy TAPE & 3D Mercy TAPEChildren'S Mercy Hospital · 2015 · cites it directly1descendant
  • K191174Mercy babyTAPEChildren'S Mercy Hospital · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K790089Tape MeasurePfizer, Inc.1979—
+1K1424692D Mercy TAPE & 3D Mercy TAPEChildren'S Mercy Hospital2015—
+2K191174Mercy babyTAPEChildren'S Mercy Hospital2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201910
FIG. 1 — Lineage of K790089, 1979–2019Source: 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 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K1424692D Mercy TAPE & 3D Mercy TAPEChildren'S Mercy Hospital20151

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, K142469 (Children'S Mercy Hospital, 2015) has gone furthest, with 1 descendant of its own.

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—
Cite this page

510(k) Report. “K790089: Tape Measure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790089

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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