510(k) · Cleared
ClearedPediatric Positioner Pad Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Coils (Usa Instruments, Inc.) · KXH Cradle, Patient, Radiologic
Cleared on Nov 16, 2012 as substantially equivalent to K930124 (Octostop, Inc., 1994) and 1 other predicate after a 116-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Nov 16, 2012
- Review
- 116 days
- Class
- Class I
- Product code
- KXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930124 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK930124 Variant of Octostop and OctopaqueOctostop, Inc. · 1994
- This deviceK122174 Pediatric Positioner Pad SetGe Healthcare Coils (Usa Instruments, Inc.) · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930124 | Variant of Octostop and Octopaque | Octostop, Inc. | 1994 | — |
| 0 (this device) | K122174 | Pediatric Positioner Pad Set | Ge Healthcare Coils (Usa Instruments, Inc.) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 KXH? 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 |
|---|---|---|---|
| * | K930124 | Variant of Octostop and OctopaqueSummary page 1…diologic patient cradle Classification Names: 21 CFR 892.1830, Cradle, Patient, Radiologic Product Code: KXH Predicate Device(s): K930124, Variant of Octostop and Octopaque K0303 17, Model 1300GE-64 - Pediatric Positioner… | 1994 |
| * | K030317 | Model 1300GE-64: Pediatric PositionerSummary page 1…radle, Patient, Radiologic Product Code: KXH Predicate Device(s): K930124, Variant of Octostop and Octopaque K0303 17, Model 1300GE-64 - Pediatric Positioner 5-2… | 2003 |
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 KXH devicesKXH Cradle, Patient, Radiologic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KXH
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KXH
Too few KXH 510(k)s in any year since 2007 to give a median.
Recalls per year · KXH
No recall names KXH since 2007.
Adverse event reports per year · KXH
No MAUDE report names KXH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pediatric Positioner Pad Set is indicated for use with newborn and infant patients up to 2 years of age or up to 12kg. The Pediatric Positioner Pad Set is indicated for use in conjunction with MR brain, spine, and neurovascular surface coils for use on 1.5T and 3.OT GE MRI Systems for positioning of the pediatric patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122174: Pediatric Positioner Pad Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122174
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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