510(k) · Cleared
ClearedP-POD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Apr 18, 2014 as substantially equivalent to K072566 (Hanger Prosthetics & Orthotics, Inc., 2008) and 1 other predicate after a 163-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Apr 18, 2014
- Review
- 163 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN980001 (1998). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN980001 Dynamic Orthotic Cranioplasty Band; Doc BandCranial Technologies, Inc. · 1998
- 2 generations backK014012 Doc BandCranial Technologies, Inc. · 2002
- 1 generation backK072566 Hanger Cranial BandHanger Prosthetics & Orthotics, Inc. · 2008
- This deviceK133397 P-PODP-Pod · 2014
- Descendant · cites it directly · 0 of its ownK193383 SnugKapHeadstart, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K193383SnugKapHeadstart, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN980001 | Dynamic Orthotic Cranioplasty Band; Doc Band | Cranial Technologies, Inc. | 1998 | — |
| −2 | K014012 | Doc Band | Cranial Technologies, Inc. | 2002 | — |
| −1 | K072566 | Hanger Cranial Band | Hanger Prosthetics & Orthotics, Inc. | 2008 | — |
| 0 (this device) | K133397 | P-POD | P-Pod | 2014 | — |
| +1 | K193383 | SnugKap | Headstart, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 MVA? 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 MVA device
- #1 K230444 Talee, Talee PostOpscore 11.9 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K072566 | Hanger Cranial BandSummary page 1…e Cranial Orthosis Code Class/fication MVVA 21 CFR 882.5970: Class 11 Preicate Devices K072566 Hanger Cranial Band T _________________________K021918 Clarren Helmet Device Description The Lorica Scien… | 2008 |
| * | K021918 | Clarren Helmet (Orthomerica)Summary page 1…cation MVVA 21 CFR 882.5970: Class 11 Preicate Devices K072566 Hanger Cranial Band T _________________________K021918 Clarren Helmet Device Description The Lorica Scientific LLC P-POD Plagiocephaly Helmet is a Class 11cranial orthos… | 2002 |
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 |
|---|---|---|---|
| K193383 | SnugKap | 2021 | 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 16 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K193383 (Headstart, Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K072566.
How does its category compare?
All MVA devicesMVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MVA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MVA
209in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVA
No recall names MVA since 2007.
Adverse event reports per year · MVA
1in 2022
MAUDE reports naming product code MVA, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 3 | 104 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 114 | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | 209 | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The P-POD Plagiocephaly Orthosis Device is intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is intended to treat infants from four to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133397: P-POD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133397
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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