510(k) Report

510(k) · Cleared

Cleared

Model 3D3 Osmometer

K925970510(k) TraditionalCleared Jul 9, 1993226-day reviewClass I21 CFR 862.2730

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

Advanced Instruments, Inc. · JJM Osmometer For Clinical Use

Cleared on Jul 9, 1993 after a 226-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 9, 1993
Review
226 days
Class
Class I
Product code
JJM
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 K925970Source: 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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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 JJM devices

JJM Osmometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJM

FDA has decided no JJM device since 2007.

Median 510(k) review, days · JJM

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

Recalls per year · JJM

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · JJM

No MAUDE report names JJM since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—20
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Advanced Instruments, Inc.

16 FDA decisions under this applicant name. See the company

  • K152776Glocyte Automated Cell Counter SystemAdvanced Instruments, Inc. · 20161 recall
  • K120631Patient MonitorAdvanced Instruments, Inc. · 2012
  • K112465Vital Signs MonitorAdvanced Instruments, Inc. · 2011
  • K965036The Advanced Osmometer (3900)Advanced Instruments, Inc. · 1997
  • K962056Advanced Micro-Osmometer Model 3300Advanced Instruments, Inc. · 1996

Recent decisions in JJM

The JJM category page

  • K965036The Advanced Osmometer (3900)Advanced Instruments, Inc. · 1997
  • K962056Advanced Micro-Osmometer Model 3300Advanced Instruments, Inc. · 1996
  • K911092Osmometer Model 2400Advanced Instruments, Inc. · 1991
  • K873642Osmometer Model 110Advanced Instruments, Inc. · 1987
  • K843997AO-10 Automated OsmometerbioMerieux, Inc. · 1984

https://510kreport.com/device/K925970 · printed Nov 5, 2026

Cite this page

510(k) Report. “K925970: Model 3D3 Osmometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925970

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