510(k) · Cleared
ClearedSnugKap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Headstart, Ltd. · MVA Orthosis, Cranial
Cleared on Jun 7, 2021 as substantially equivalent to K180568 (Eastern Cranial Affiliates, LLC, 2018) and 3 other predicates after a 550-day review. Its family tree reaches back 13 generations to 2000.
- Decided
- Jun 7, 2021
- Review
- 550 days
- Class
- Class II
- Product code
- MVA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K001167 (2000). 28 ancestors in all, the oldest DEN980001 (1998). No later device cites it as a predicate yet.
- Root · 13 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 9 generations between
- 3 generations backK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- 2 generations backK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- 1 generation backK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
- This deviceK193383 SnugKapHeadstart, Ltd. · 2021
Show all 13 generations
- Root · 13 generations backK001167 Opi BandOrthomerica Products, Inc. · 2000
- 12 generations backK021207 StarlightOrthomerica Products, Inc. · 2002
- 11 generations backK081994 StarlightOrthomerica Products, Inc. · 2008
- 10 generations backK082950 StarbandOrthomerica Products, Inc. · 2008
- 9 generations backK111609 Boston BandBoston Brace Intl., Inc. · 2011
- 8 generations backK124023 StarbandOrthomerica Products, Inc. · 2013
- 7 generations backK133250 StarlightOrthomerica Products, Inc. · 2014
- 6 generations backK140353 Starband and StarlightOrthomerica Products, Inc. · 2014
- 5 generations backK141842 Starband, StarlightOrthomerica Products, Inc. · 2014
- 4 generations backK151147 STARband, STARlightOrthomerica Products, Inc. · 2015
- 3 generations backK151979 STARband, STARlightOrthomerica Products, Inc. · 2015
- 2 generations backK161138 St. Louis BandOrthomerica Products, Inc. · 2016
- 1 generation backK180109 STARband, STARlight, St. Louis BandOrthomerica Products, Inc. · 2018
- This deviceK193383 SnugKapHeadstart, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001167 | Opi Band | Orthomerica Products, Inc. | 2000 | — |
| −12 | K021207 | Starlight | Orthomerica Products, Inc. | 2002 | — |
| −11 | K081994 | Starlight | Orthomerica Products, Inc. | 2008 | — |
| −10 | K082950 | Starband | Orthomerica Products, Inc. | 2008 | — |
| −9 | K111609 | Boston Band | Boston Brace Intl., Inc. | 2011 | — |
| −8 | K124023 | Starband | Orthomerica Products, Inc. | 2013 | — |
| −7 | K133250 | Starlight | Orthomerica Products, Inc. | 2014 | — |
| −6 | K140353 | Starband and Starlight | Orthomerica Products, Inc. | 2014 | — |
| −5 | K141842 | Starband, Starlight | Orthomerica Products, Inc. | 2014 | — |
| −4 | K151147 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| −3 | K151979 | STARband, STARlight | Orthomerica Products, Inc. | 2015 | — |
| −2 | K161138 | St. Louis Band | Orthomerica Products, Inc. | 2016 | — |
| −1 | K180109 | STARband, STARlight, St. Louis Band | Orthomerica Products, Inc. | 2018 | — |
| 0 (this device) | K193383 | SnugKap | Headstart, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 11.8 · 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? (4)
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 |
|---|---|---|---|
| * | K180568 | KidCapSummary page 4…Device Name K Number Primary Predicate Eastern Cranial Affiliates, LLC KidCap K180568 Reference Devices Lorica Scientific, LLC P-POD K133397… | 2018 |
| * | K133397 | P-PODSummary page 4…tes, LLC KidCap K180568 Reference Devices Lorica Scientific, LLC P-POD K133397 Orthomerica Products, Inc. STARBand, STARlight, St. Louis Band K180109 Fairview Orthopedic Labor… | 2014 |
| * | K180109 | STARband, STARlight, St. Louis BandSummary page 4…Lorica Scientific, LLC P-POD K133397 Orthomerica Products, Inc. STARBand, STARlight, St. Louis Band K180109 Fairview Orthopedic Laboratory Molded Cranial Helmet K012920… | 2018 |
| * | K012920 | Molded Cranial HelmetSummary page 4…Orthomerica Products, Inc. STARBand, STARlight, St. Louis Band K180109 Fairview Orthopedic Laboratory Molded Cranial Helmet K012920 K193383, Page 2 of 7 Indication… | 2001 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 28 ancestors has a recall.
How does its category compare?
All MVA devicesMVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 SnugKap is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional Plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
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/K193383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193383: SnugKap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193383
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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