510(k) Report

510(k) · Cleared

Cleared

Clinitek 200 Semi-Automated Urinalysis

K842237510(k) TraditionalCleared Aug 15, 198471-day reviewClass I21 CFR 862.2900

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

Miles Laboratories, Inc. · KQO Automated Urinalysis System

Cleared on Aug 15, 1984 after a 71-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
Aug 15, 1984
Review
71 days
Class
Class I
Product code
KQO
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared19801990200020102020
  1. This deviceK842237 Clinitek 200 Semi-Automated UrinalysisMiles Laboratories, Inc. · 1984
  2. Descendant · cites it directly · 0 of its ownK980047 Uriscan S-300 Semi-Automated Urine Chemistry AnalyzerYeongdong Pharmaceutical Corp. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K980047Uriscan S-300 Semi-Automated Urine Chemistry AnalyzerYeongdong Pharmaceutical Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K842237Clinitek 200 Semi-Automated UrinalysisMiles Laboratories, Inc.1984—
+1K980047Uriscan S-300 Semi-Automated Urine Chemistry AnalyzerYeongdong Pharmaceutical Corp.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K842237, 1984–1998Source: 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 KQO? 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 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
K980047Uriscan S-300 Semi-Automated Urine Chemistry AnalyzerYeongdong Pharmaceutical Corp.19980

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, K980047 (Yeongdong Pharmaceutical Corp., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KQO devices

KQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQO

2in 2015

2007: 12009: 12010: 22011: 22013: 12014: 12015: 2
2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KQO

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

Recalls per year · KQO

1in 2021

2010: 72011: 22013: 12016: 12019: 22021: 12026 (partial year): 2
2007high 7 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KQO

12in 2025

2007: 12008: 42009: 92010: 32011: 82012: 152013: 922014: 1062015: 2382016: 3732017: 202018: 252019: 642020: 212021: 132022: 152023: 192024: 202025: 12
2007high 373 (2016) · low 1 (2007)2025

MAUDE reports naming product code KQO, 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
20071—01
20080—04
20091—09
20102—73
20112—28
20120—015
20131—192
20141—0106
20152—0238
20160—1373
20170—020
20180—025
20190—264
20200—021
20210—113
20220—015
20230—019
20240—020
20250—012
20260—2—

More from Miles Laboratories, Inc.

160 FDA decisions under this applicant name. See the company

  • K880605Labeling Change for Cutter Pureflo Plus IV FilterMiles Laboratories, Inc. · 1988
  • K874909Micro-Bumintest Reagent TabletsMiles Laboratories, Inc. · 1988
  • K875079Modified Seralyzer Alt/SGPT Reag. Strips & ModuleMiles Laboratories, Inc. · 1988
  • K871835Glucometer QC Blood Meter, Ames Gluco System PrintMiles Laboratories, Inc. · 1987
  • K872120Seralyzer Iii Blood Chemistry AnalyzerMiles Laboratories, Inc. · 1987

Recent decisions in KQO

The KQO category page

  • K141874Uriscan OptimaYd Diagnostics Corp. · 2015
  • K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine ControlACON Laboratories, Inc. · 2015
  • K140717Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration KitSiemens Healthcare Diagnostics · 2014
  • K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA Urine Test Strips…Arkray, Inc. · 20131 recall
  • K102188Cybow Reader, Models 300 & 720DFI Co., Ltd. · 2011

https://510kreport.com/device/K842237 · printed Nov 4, 2026

Cite this page

510(k) Report. “K842237: Clinitek 200 Semi-Automated Urinalysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K842237

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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