510(k) Report

510(k) · Cleared

Cleared

Plethysmograph, Strain Gauge

K782132510(k) TraditionalCleared Feb 26, 197961-day reviewClass II21 CFR 870.2780

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

Medasonics, Inc. · JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Cleared on Feb 26, 1979 after a 61-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
Feb 26, 1979
Review
61 days
Class
Class II
Product code
JOM
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared19801990200020102020
  1. This deviceK782132 Plethysmograph, Strain GaugeMedasonics, Inc. · 1979
  2. Descendant · cites it directly · 0 of its ownK983900 VenometerAdvanced Medical Technology, Ltd. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K983900VenometerAdvanced Medical Technology, Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K782132Plethysmograph, Strain GaugeMedasonics, Inc.1979—
+1K983900VenometerAdvanced Medical Technology, Ltd.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K782132, 1979–1999Source: 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 JOM? 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 JOM device

  1. #1 K220527 PADnet Xpressscore 5.1 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K983900VenometerAdvanced Medical Technology, Ltd.19990

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, K983900 (Advanced Medical Technology, Ltd., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JOM devices

JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOM

2in 2022

2007: 22009: 12010: 22011: 12012: 12013: 22015: 22017: 12018: 12020: 22021: 12022: 2
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOM

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

Recalls per year · JOM

No recall names JOM since 2007.

Adverse event reports per year · JOM

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code JOM, 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
20072—01
20080—00
20091—00
20102—00
20111—00
20121—00
20132—00
20140—00
20152—00
20160—00
20171—00
20181—00
20190—00
20202—00
20211—00
20222—00
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K782132: Plethysmograph, Strain Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K782132

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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