510(k) · Cleared
ClearedPneumo-Matic Insufflation Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apple Medical Corp. · FHO Pneumoperitoneum Needle
Cleared on Mar 27, 1997 after a 23-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Mar 27, 1997
- Review
- 23 days
- Class
- Class II
- Product code
- FHO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970788 Pneumo-Matic Insufflation NeedleApple Medical Corp. · 1997
- Descendant · cites it directly · 0 of its ownK121370 Vectec Disposable Pneumoperitoneum NeedleVectec · 2013
Most influential descendants
Showing 1 of 1 · See all- K121370Vectec Disposable Pneumoperitoneum NeedleVectec · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970788 | Pneumo-Matic Insufflation Needle | Apple Medical Corp. | 1997 | — |
| +1 | K121370 | Vectec Disposable Pneumoperitoneum Needle | Vectec | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (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 |
|---|---|---|---|
| * | — | Dexide, Inc. Pneumo-Needle Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121370 | Vectec Disposable Pneumoperitoneum Needle | 2013 | 0 |
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, K121370 (Vectec, 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FHO devicesFHO Pneumoperitoneum Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
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/K970788 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970788: Pneumo-Matic Insufflation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970788
Report an extraction error
Are you the manufacturer?
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