510(k) Report

510(k) · Cleared

Cleared

Perceptive Systems Inc Psicom 217 Karyotyping Syst

K861974510(k) TraditionalCleared Aug 4, 198675-day reviewClass II21 CFR 864.5260

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

Perceptive Systems, Inc. · LNJ Analyzer, Chromosome, Automated

Cleared on Aug 4, 1986 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 4, 1986
Review
75 days
Class
Class II
Product code
LNJ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K861974Source: 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 has not posted a summary or statement for it, 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 LNJ devices

LNJ Analyzer, Chromosome, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNJ

FDA has decided no LNJ device since 2007.

Median 510(k) review, days · LNJ

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

Recalls per year · LNJ

No recall names LNJ since 2007.

Adverse event reports per year · LNJ

1in 2007

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

MAUDE reports naming product code LNJ, 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—01
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 Perceptive Systems, Inc.

2 FDA decisions under this applicant name. See the company

  • K952778CheshirePerceptive Systems, Inc. · 1995

Recent decisions in LNJ

The LNJ category page

  • K050236FishviewApplied Spectral Imaging, Ltd. · 2005
  • K012103Bandview SystemApplied Spectral Imaging, Ltd. · 2001
  • K940240IkarosMetasystems GmbH · 1995
  • K912085Aclaims-ISW-Technology · 1991
  • K902311Genevision - Computer Assisted Chromosome Karyo.Applied Imaging Corp. · 1990

https://510kreport.com/device/K861974 · printed Nov 6, 2026

Cite this page

510(k) Report. “K861974: Perceptive Systems Inc Psicom 217 Karyotyping Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861974

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