510(k) Report

510(k) · Cleared

Cleared

Filtermate Universal Harvester

K924907510(k) TraditionalCleared Dec 1, 199263-day reviewClass I21 CFR 866.2500

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

Packard Instrument Co., Inc. · JTC Device, Microtiter Diluting/Dispensing

Cleared on Dec 1, 1992 after a 63-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 1, 1992
Review
63 days
Class
Class I
Product code
JTC
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 K924907Source: 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 JTC? 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 JTC devices

JTC Device, Microtiter Diluting/Dispensing: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JTC

FDA has decided no JTC device since 2007.

Median 510(k) review, days · JTC

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

Recalls per year · JTC

1in 2009

2007: 12008: 12009: 1
2007high 1 (2007) · low 0 (2010)2026

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

Adverse event reports per year · JTC

8in 2025

2007: 1,1182008: 9192009: 3882010: 1902011: 472012: 12013: 12014: 22015: 12019: 1022020: 22021: 82022: 262023: 152024: 102025: 8
2007high 1,118 (2007) · low 0 (2016)2025

MAUDE reports naming product code JTC, 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—11,118
20080—1919
20090—1388
20100—0190
20110—047
20120—01
20130—01
20140—02
20150—01
20160—00
20170—00
20180—00
20190—0102
20200—02
20210—08
20220—026
20230—015
20240—010
20250—08
20260—0—

More from Packard Instrument Co., Inc.

4 FDA decisions under this applicant name. See the company

  • K913664Rosys Models 100 and 200Packard Instrument Co., Inc. · 1991
  • K901808Micromate 196 Model A961960Packard Instrument Co., Inc. · 1990
  • K883749Probe (TM) Models 700 and 1000Packard Instrument Co., Inc. · 1988

Recent decisions in JTC

The JTC category page

  • K901808Micromate 196 Model A961960Packard Instrument Co., Inc. · 1990
  • K894645Immulon 1,2,3,and 4 Dividastrips TMDynatech Laboratories, Inc. · 1989
  • K892369Multi-Probe Head PlusHamilton Co. · 1989
  • K891766Genetic Systems Microplate Strip WasherGenetic Systems Corp. · 1989
  • K891765Genetic Systems Pipettor/DilutorGenetic Systems Corp. · 1989

https://510kreport.com/device/K924907 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924907: Filtermate Universal Harvester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924907

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