510(k) Report

510(k) · Cleared

Cleared

Isorobic Skinfold Caliper

K810116510(k) TraditionalCleared Feb 4, 198120-day reviewClass I21 CFR 888.4150

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

Fitness Motivation Institute of America · KTZ Caliper

Cleared on Feb 4, 1981 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Feb 4, 1981
Review
20 days
Class
Class I
Product code
KTZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared19801990200020102020
  1. This deviceK810116 Isorobic Skinfold CaliperFitness Motivation Institute of America · 1981
  2. Descendant · cites it directly · 2 of its ownK082147 Bodymetrix BX2000Intelametrix, Inc. · 2009
  3. Descendant · 2 generations on · 1 of its ownK202514 EchoS FamilyEcholight S.P.A · 2021
  4. Descendant · 3 generations on · 0 of its ownK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022

Most influential descendants

Showing 3 of 3 · See all
  • K082147Bodymetrix BX2000Intelametrix, Inc. · 2009 · cites it directly2descendants
  • K202514EchoS FamilyEcholight S.P.A · 2021 · 2 generations on1descendant
  • K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K810116Isorobic Skinfold CaliperFitness Motivation Institute of America1981—
+1K082147Bodymetrix BX2000Intelametrix, Inc.2009—
+2K202514EchoS FamilyEcholight S.P.A2021—
+3K212851EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
202110
202210
FIG. 1 — Lineage of K810116, 1981–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 KTZ? 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
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? (3)

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

NumberDeviceApplicantDecidedDescendants
K082147Bodymetrix BX2000Intelametrix, Inc.20092

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, K082147 (Intelametrix, Inc., 2009) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KTZ devices

KTZ Caliper: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTZ

FDA has decided no KTZ device since 2007.

Median 510(k) review, days · KTZ

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

Recalls per year · KTZ

No recall names KTZ since 2007.

Adverse event reports per year · KTZ

1in 2025

2012: 12013: 12015: 22019: 22022: 22023: 22024: 22025: 1
2007high 2 (2015) · low 0 (2007)2025

MAUDE reports naming product code KTZ, 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—00
20100—00
20110—00
20120—01
20130—01
20140—00
20150—02
20160—00
20170—00
20180—00
20190—02
20200—00
20210—00
20220—02
20230—02
20240—02
20250—01
20260—0—

Recent decisions in KTZ

The KTZ category page

  • K921266NK Medical Micrometer, Model MC001Nk Biotechnical Engineering Co. · 1992
  • K841687Skyndex Electronic Body Fat CalculaCaldwell, Justiss & Co., Inc. · 1984
  • K831898ScolimeterDr. Micheal A. Sabia · 1983
  • K820659A CaliperTwin City Surgical, Inc. · 1982
  • K800363Parke-Davis Total Knee ProsthesisWarner-Lambert Co. · 1980

https://510kreport.com/device/K810116 · printed Nov 6, 2026

Cite this page

510(k) Report. “K810116: Isorobic Skinfold Caliper.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810116

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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