510(k) · Cleared
ClearedKyphon Inflation Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Spine, LLC · HRX Arthroscope
Cleared on Jan 24, 2011 as substantially equivalent to K032840 (Atrion Medical Products, Inc., 2004) after an 84-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jan 24, 2011
- Review
- 84 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953522 (1996). 5 ancestors in all, the oldest K955869 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 3 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- 2 generations backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- 1 generation backK032840 Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
- This deviceK103231 Kyphon Inflation SyringeMedtronic Spine, LLC · 2011
- Descendant · cites it directly · 0 of its ownK113742 KMC Kyphoplasty SystemShanghai Kinetic Medical Co., Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113742KMC Kyphoplasty SystemShanghai Kinetic Medical Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −3 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| −2 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| −1 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| 0 (this device) | K103231 | Kyphon Inflation Syringe | Medtronic Spine, LLC | 2011 | — |
| +1 | K113742 | KMC Kyphoplasty System | Shanghai Kinetic Medical Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K032840 | Atrion Medical QL Inflation DeviceSummary page 1…1221 Crossman Avenue Sunnyvale, CA 94089 Phone: (408) 548-5334 Predicate Atrion Medical QL® Inflation Device: K032840 (cleared on March 03, 2004) Device(s): Intended Use The Kyphon® Inflation Syringe is intended to be used to inflate an… | 2004 |
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 |
|---|---|---|---|
| K113742 | KMC Kyphoplasty System | 2012 | 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K113742 (Shanghai Kinetic Medical Co., Ltd., 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K032840.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Kyphon® Inflation Syringe is intended to be used to inflate and deflate inflatable devices (including Inflatable Bone Tamps) and to measure the pressure within the inflatable device during the procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103231: Kyphon Inflation Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103231
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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