510(k) · Cleared
ClearedStandard Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Bariatrics · GDJ Clamp, Surgical, General & Plastic Surgery
Cleared on May 2, 2016 after a 164-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- May 2, 2016
- Review
- 164 days
- Class
- Class I
- Product code
- GDJ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK153358 Standard ClampStandard Bariatrics · 2016
- Descendant · cites it directly · 2 of its ownK161720 Standard ClampStandard Bariatrics · 2016
- Descendant · 2 generations on · 1 of its ownK170379 Disposable Standard ClampStandard Bariatrics · 2017
- Descendant · 3 generations on · 0 of its ownK181608 Disposable Standard ClampStandard Bariatrics · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K153358 | Standard Clamp | Standard Bariatrics | 2016 | — |
| +1 | K161720 | Standard Clamp | Standard Bariatrics | 2016 | — |
| +2 | K170379 | Disposable Standard Clamp | Standard Bariatrics | 2017 | — |
| +3 | K181608 | Disposable Standard Clamp | Standard Bariatrics | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
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 GDJ? 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 |
|---|---|---|---|
| * | — | Doyen Atraumatic Bowel Clamp Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161720 | Standard Clamp | 2016 | 2 |
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, K161720 (Standard Bariatrics, 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All GDJ devicesGDJ Clamp, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GDJ
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GDJ
Too few GDJ 510(k)s in any year since 2007 to give a median.
Recalls per year · GDJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GDJ
21in 2025
MAUDE reports naming product code GDJ, 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 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 1 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 20 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 1 | 67 |
| 2025 | 0 | — | 0 | 21 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Standard Clamp is indicated for use in open procedures to grasp, clamp, and manipulate soft tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153358 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153358: Standard Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153358
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026