510(k) Report

510(k) · Cleared

Cleared

Mas Liquid Urinalysis Control

K935062510(k) TraditionalCleared Jan 27, 199499-day reviewClass I21 CFR 862.1660

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

Medical Analysis Systems, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)

Cleared on Jan 27, 1994 after a 99-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jan 27, 1994
Review
99 days
Class
Class I
Product code
JJW
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK935062 Mas Liquid Urinalysis ControlMedical Analysis Systems, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK965157 Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1Boehringer Mannheim Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K965157Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1Boehringer Mannheim Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935062Mas Liquid Urinalysis ControlMedical Analysis Systems, Inc.1994—
+1K965157Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1Boehringer Mannheim Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K935062, 1994–1997Source: 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 JJW? 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K965157Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1Boehringer Mannheim Corp.19970

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, K965157 (Boehringer Mannheim Corp., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJW devices

JJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJW

1in 2017

2007: 22009: 12011: 22014: 12015: 12017: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJW

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

Recalls per year · JJW

2in 2024

2007: 12012: 72013: 12022: 22024: 2
2007high 7 (2012) · low 0 (2008)2026

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

Adverse event reports per year · JJW

1in 2022

2007: 22009: 12012: 12013: 242022: 1
2007high 24 (2013) · low 0 (2008)2025

MAUDE reports naming product code JJW, 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
20072—12
20080—00
20091—01
20100—00
20112—00
20120—71
20130—124
20141—00
20151—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—21
20230—00
20240—20
20250—00
20260—0—

More from Medical Analysis Systems, Inc.

107 FDA decisions under this applicant name. See the company

  • K042717Mas, Dade and Liquid Assayed Diabetes ControlMedical Analysis Systems, Inc. · 2004
  • K041194Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HMedical Analysis Systems, Inc. · 2004
  • K040880Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3Medical Analysis Systems, Inc. · 2004
  • K032826Mas Par TDMMedical Analysis Systems, Inc. · 2003
  • K032335Mas Cardioimmune Probnp, Mas Cardioimmune TLMedical Analysis Systems, Inc. · 2003

Recent decisions in JJW

The JJW category page

  • K170091UA-Cellular CompleteStreck · 2017
  • K142262Aution Check PlusQuantimetrix Corp. · 2015
  • K131444UA-Cellular CompleteStreck · 2014
  • K110846Randox Urinalysis Controls, Levels 1 and 2Randox Laboratories Limited · 20111 recall
  • K103387Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine ControlACON Laboratories, Inc. · 2011

https://510kreport.com/device/K935062 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935062: Mas Liquid Urinalysis Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935062

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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