510(k) Report

510(k) · Cleared

Cleared

Medicine Cup

K791345510(k) TraditionalCleared Aug 3, 197922-day reviewClass I21 CFR 880.6430

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

General Clinical Plastics Corp. · KYW Container, Liquid Medication, Graduated

Cleared on Aug 3, 1979 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 3, 1979
Review
22 days
Class
Class I
Product code
KYW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K791345Source: 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.

Planning a device in KYW? 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?

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 KYW devices

KYW Container, Liquid Medication, Graduated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KYW

FDA has decided no KYW device since 2007.

Median 510(k) review, days · KYW

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

Recalls per year · KYW

1in 2025

2022: 82025: 1
2007high 8 (2022) · low 0 (2007)2026

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

Adverse event reports per year · KYW

1in 2025

2007: 32010: 22011: 12015: 12016: 12017: 32018: 232019: 382020: 242021: 152022: 352023: 192024: 132025: 1
2007high 38 (2019) · low 0 (2008)2025

MAUDE reports naming product code KYW, 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—03
20080—00
20090—00
20100—02
20110—01
20120—00
20130—00
20140—00
20150—01
20160—01
20170—03
20180—023
20190—038
20200—024
20210—015
20220—835
20230—019
20240—013
20250—11
20260—0—

More from General Clinical Plastics Corp.

4 FDA decisions under this applicant name. See the company

  • K792211Speciman Cup & Emesis BasinGeneral Clinical Plastics Corp. · 1979
  • K791348Round Washbasin & Rectangle WashbasinGeneral Clinical Plastics Corp. · 1979
  • K791346Disposable BedpanGeneral Clinical Plastics Corp. · 1979

Recent decisions in KYW

The KYW category page

  • K800213Pharmacy Additive Syringe SetCutter Laboratories, Inc. · 1980

https://510kreport.com/device/K791345 · printed Nov 6, 2026

Cite this page

510(k) Report. “K791345: Medicine Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791345

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