510(k) · Cleared
ClearedPajunk Disposable Balloons and Balloon Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · GCJ Laparoscope, General & Plastic Surgery
Cleared on Apr 16, 2009 as substantially equivalent to K935426 (Origin Medsystems, Inc., 1994) and 2 other predicates after a 38-day review. Its family tree reaches back 3 generations to 1994. 9 later devices descend from it.
- Decided
- Apr 16, 2009
- Review
- 38 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944418 (1994). 12 ancestors in all, the oldest K926010 (1993). 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK944418 The Spacemaker and the Spacemaker IIGeneral Surgical Innovations · 1994
- 2 generations backK962702 Spacemaker Serial Surgical Balloon Dissector, with Cannula, with…General Surgical Innovations · 1997
- 1 generation backK973046 Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical…General Surgical Innovations · 1998
- This deviceK090631 Pajunk Disposable Balloons and Balloon SystemsPAJUNK GmbH Medizintechnologie · 2009
- Descendant · cites it directly · 7 of its ownK092726 Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010
- Descendant · 2 generations on · 6 of its ownK102766 Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 3 of its ownK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K092726Mesh GPS - Large, Small, SM, SM SmallSurgical Structures, Ltd. · 2010 · cites it directly7descendants
- K102766Composix L/P Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2010 · 2 generations on6descendants
- K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · 3 generations on5descendants
- K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 3 generations on4descendants
- K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944418 | The Spacemaker and the Spacemaker II | General Surgical Innovations | 1994 | — |
| −2 | K962702 | Spacemaker Serial Surgical Balloon Dissector, with Cannula, with Visualization… | General Surgical Innovations | 1997 | — |
| −1 | K973046 | Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon… | General Surgical Innovations | 1998 | — |
| 0 (this device) | K090631 | Pajunk Disposable Balloons and Balloon Systems | PAJUNK GmbH Medizintechnologie | 2009 | — |
| +1 | K092726 | Mesh GPS - Large, Small, SM, SM Small | Surgical Structures, Ltd. | 2010 | — |
| +2 | K102766 | Composix L/P Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2010 | 2 |
| +3 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| +3 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
| +4 | K130968 | Ventralight ST Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2013 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 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 GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K935426 | Preperitoneal Distention Balloon System Our reading of the summary gave K936426, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Preperitoneal Distention Balloon System”. | 1994 |
| * | K973046 | Spacemaker Surgical Balloon Dissector, Spacemaker II Surgical Balloon Dissector, SaphtrakSummary page 2…e besic design has been cleared by FDA in K012771. Predicate devices with identical indications of use are: 1. K936426 Preperitoneal Distention Balloon System 2. K973046 Spacemaker surgical Balloon dissector, Spacemaker 3. K042412 Modified Spacemaker system The detailed discussion of substantia… | 1998 |
| * | K042412 | Modified Spacemaker SystemSummary page 2…ces with identical indications of use are: 1. K936426 Preperitoneal Distention Balloon System 2. K973046 Spacemaker surgical Balloon dissector, Spacemaker 3. K042412 Modified Spacemaker system The detailed discussion of substantial eqivalence can be found in Section 12 of this submission. The s… | 2004 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K092726 (Surgical Structures, Ltd., 2010) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K935426.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The PAJUNK Balloon systems are indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and / or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and / or tissue separation in extraperitoneal procedures, such as in hernia repair.
The PAJUNK Obturator is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090631 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090631: Pajunk Disposable Balloons and Balloon Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090631
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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