510(k) Report

510(k) · Cleared

Cleared

Meddrains

K931607510(k) TraditionalCleared Aug 6, 1993127-day reviewClass I21 CFR 878.4200

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

Armm, Inc. · GBN Catheter, Pediatric, General & Plastic Surgery

Cleared on Aug 6, 1993 after a 127-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Aug 6, 1993
Review
127 days
Class
Class I
Product code
GBN
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 K931607Source: 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 GBN devices

GBN Catheter, Pediatric, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBN

FDA has decided no GBN device since 2007.

Median 510(k) review, days · GBN

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

Recalls per year · GBN

1in 2014

2014: 1, 1 Class I
2007high 1 (2014) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GBN

No MAUDE report names GBN since 2007.

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—1 (1)0
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Armm, Inc.

4 FDA decisions under this applicant name. See the company

  • K981286Superflow Irrigation and Aspiration Tubing SetsArmm, Inc. · 1998
  • K923201Endosi Suction IrrigatorArmm, Inc. · 1993
  • K922245Super-Flow TubingArmm, Inc. · 1993

Recent decisions in GBN

The GBN category page

  • K802783Surgeons Choice Staple, Remove/ImplantHospital Products Intl. · 1980

https://510kreport.com/device/K931607 · printed Nov 4, 2026

Cite this page

510(k) Report. “K931607: Meddrains.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931607

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