510(k) Report

510(k) · Decided

Decided

Drug, Insurance, Urinalysis, Blood/Urine Test Kits

K931474510(k) TraditionalDecided May 10, 1994412-day reviewClass I21 CFR 864.3250

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

Gbf Medical Group · KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile

Cleared on May 10, 1994 after a 412-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 10, 1994
Review
412 days
Class
Class I
Product code
KDW
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K931474Source: 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 lists a 510(k) statement for it but has not posted the file, 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 KDW devices

KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KDW

FDA has decided no KDW device since 2007.

Median 510(k) review, days · KDW

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

Recalls per year · KDW

No recall names KDW since 2007.

Adverse event reports per year · KDW

1in 2024

2018: 32020: 32023: 12024: 1
2007high 3 (2018) · low 0 (2007)2025

MAUDE reports naming product code KDW, 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—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—03
20190—00
20200—03
20210—00
20220—00
20230—01
20240—01
20250—00
20260—0—

Recent decisions in KDW

The KDW category page

  • K970580Sasi-DC1TSSubstance Abuse Specialties, Inc. · 1997
  • K951122Capitol Urine Drug Screen Collection KitHarry A. Schlakman · 1995
  • K913967Dox Tamperproof Specimen Container SystemDoxtech, Inc. · 1991

https://510kreport.com/device/K931474 · printed Nov 5, 2026

Cite this page

510(k) Report. “K931474: Drug, Insurance, Urinalysis, Blood/Urine Test Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K931474

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