510(k) · Cleared
ClearedPenrose Drain Models 6001 - 6007
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sil-Med Corp. · GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Cleared on Mar 11, 1996 after a 60-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 11, 1996
- Review
- 60 days
- Class
- Class I
- Product code
- GCY
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GCY? 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Davol Gravity Drain Named without a submission number |
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 GCY devicesGCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GCY
FDA has decided no GCY device since 2007.
Median 510(k) review, days · GCY
Too few GCY 510(k)s in any year since 2007 to give a median.
Recalls per year · GCY
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GCY
178in 2025
MAUDE reports naming product code GCY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 246 |
| 2008 | 0 | — | 38 | 205 |
| 2009 | 0 | — | 2 | 231 |
| 2010 | 0 | — | 1 | 124 |
| 2011 | 0 | — | 12 | 58 |
| 2012 | 0 | — | 0 | 47 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 0 | — | 0 | 93 |
| 2016 | 0 | — | 0 | 145 |
| 2017 | 0 | — | 0 | 260 |
| 2018 | 0 | — | 1 | 180 |
| 2019 | 0 | — | 0 | 200 |
| 2020 | 0 | — | 0 | 202 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 96 |
| 2023 | 0 | — | 0 | 90 |
| 2024 | 0 | — | 0 | 74 |
| 2025 | 0 | — | 0 | 178 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960099: Penrose Drain Models 6001 - 6007.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960099
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026