510(k) Report

510(k) · Cleared

Cleared

Solid State Continuous Flow Control Model W/K101

K861460510(k) TraditionalCleared May 2, 198614-day reviewClass II21 CFR 866.3780

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

Widran Urological Group, Ltd. · LJK Antisera, If, Toxoplasma Gondii

Cleared on May 2, 1986 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 2, 1986
Review
14 days
Class
Class II
Product code
LJK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K861460Source: FDA 510(k) database · 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 LJK? 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?

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 LJK devices

LJK Antisera, If, Toxoplasma Gondii: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJK

FDA has decided no LJK device since 2007.

Median 510(k) review, days · LJK

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

Recalls per year · LJK

No recall names LJK since 2007.

Adverse event reports per year · LJK

1in 2013

2011: 22013: 1
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code LJK, 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—02
20120—00
20130—01
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 Widran Urological Group, Ltd.

2 FDA decisions under this applicant name. See the company

  • K822743Solid State Continuous Flow ControlWidran Urological Group, Ltd. · 1982

Recent decisions in LJK

The LJK category page

  • K974261Accurun 135 Toxoplasma Igg Positive ControlBoston Biomedica, Inc. · 1997
  • K911771Ard (TM) Antimicrobial Removal DeviceBd Becton Dickinson Vacutainer Systems Preanalytic · 1991
  • K861122The Golden Quad Test (Toxo)Microbiological Research Corp. · 1987
  • K832069Toxo Ipa Kit Ian Indirect FluorescentBionetic Laboratory Products · 1983
  • K822605Toxoplasma Gondii Antibody IggImmulok, Inc. · 1982

https://510kreport.com/device/K861460 · printed Nov 5, 2026

Cite this page

510(k) Report. “K861460: Solid State Continuous Flow Control Model W/K101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861460

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
  • Page last updated Nov 3, 2026