510(k) Report

510(k) · Cleared

Cleared

Clinitek Atlas Automated Urine Chemistry System

K932674510(k) TraditionalCleared Aug 19, 199378-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 Inc., Dental Products · KQO Automated Urinalysis System

Cleared on Aug 19, 1993 after a 78-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 19, 1993
Review
78 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 2014: 1 descendant cleared1990200020102020
  1. This deviceK932674 Clinitek Atlas Automated Urine Chemistry SystemMiles Inc., Dental Products · 1993
  2. Descendant · cites it directly · 0 of its ownK140717 Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis…Siemens Healthcare Diagnostics · 2014

Most influential descendants

Showing 1 of 1 · See all
  • K140717Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration…Siemens Healthcare Diagnostics · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932674Clinitek Atlas Automated Urine Chemistry SystemMiles Inc., Dental Products1993—
+1K140717Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette…Siemens Healthcare Diagnostics2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
FIG. 1 — Lineage of K932674, 1993–2014Source: 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
K140717Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration…Siemens Healthcare Diagnostics20140

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, K140717 (Siemens Healthcare Diagnostics, 2014) 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 Inc., Dental Products

2 FDA decisions under this applicant name. See the company

  • K933360Gluma 3 Step Bonding System/ Gluma 3 Primer/DesensitizerMiles Inc., Dental Products · 1994

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/K932674 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932674: Clinitek Atlas Automated Urine Chemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932674

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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