510(k) · Cleared
ClearedVectec Disposable Pneumoperitoneum Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vectec · FHO Pneumoperitoneum Needle
Cleared on Aug 2, 2013 as substantially equivalent to K970788 (Apple Medical Corp., 1997) and 1 other predicate after a 452-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 2, 2013
- Review
- 452 days
- Class
- Class II
- Product code
- FHO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910855 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910855 Endopath Veress NeedleSymbiosis Corp. · 1991
- This deviceK121370 Vectec Disposable Pneumoperitoneum NeedleVectec · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910855 | Endopath Veress Needle | Symbiosis Corp. | 1991 | — |
| 0 (this device) | K121370 | Vectec Disposable Pneumoperitoneum Needle | Vectec | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 FHO? 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? (2)
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 |
|---|---|---|---|
| * | K970788 | Pneumo-Matic Insufflation NeedleSummary page 2…predicate 2 Device Name: Pocum-Matic Insufflation Needle Kicndopath Veress Needle 5 10(k) Number: K970788 K910855 Manufacturer: Apple Medical Corporation Ethicon En… | 1997 |
| * | K910855 | Endopath Veress NeedleSummary page 2…e Name: Pocum-Matic Insufflation Needle Kicndopath Veress Needle 5 10(k) Number: K970788 K910855 Manufacturer: Apple Medical Corporation Ethicon Endosurgery Inc. 6. COMPARISON TO PREDI… | 1991 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All FHO devicesFHO Pneumoperitoneum Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FHO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · FHO
Too few FHO 510(k)s in any year since 2007 to give a median.
Recalls per year · FHO
No recall names FHO since 2007.
Adverse event reports per year · FHO
1in 2025
MAUDE reports naming product code FHO, 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 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121370: Vectec Disposable Pneumoperitoneum Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121370
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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