510(k) Report

510(k) · Cleared

Cleared

Danmar Products Michigan Cranial Helmet

K003630510(k) TraditionalCleared May 29, 2001186-day reviewClass II21 CFR 882.5970

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Danmar Products, Inc. · MVA Orthosis, Cranial

Cleared on May 29, 2001 after a 186-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
May 29, 2001
Review
186 days
Class
Class II
Product code
MVA
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2003: 1 descendant cleared200020052010201520202025
  1. This deviceK003630 Danmar Products Michigan Cranial HelmetDanmar Products, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK090341 Michigan Cranial Reshaping OrthosisDanmar Products, Inc. · 2010
  3. Descendant · cites it directly · 0 of its ownK013452 Danmar Products Cranial Adjustive ProsthesisDanmar Products, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K090341Michigan Cranial Reshaping OrthosisDanmar Products, Inc. · 2010 · cites it directly0descendants
  • K013452Danmar Products Cranial Adjustive ProsthesisDanmar Products, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003630Danmar Products Michigan Cranial HelmetDanmar Products, Inc.2001—
+1K090341Michigan Cranial Reshaping OrthosisDanmar Products, Inc.2010—
+1K013452Danmar Products Cranial Adjustive ProsthesisDanmar Products, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201010
FIG. 1 — Lineage of K003630, 2001–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K230444 Talee, Talee PostOpscore 11.8 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090341Michigan Cranial Reshaping OrthosisDanmar Products, Inc.20100
K013452Danmar Products Cranial Adjustive ProsthesisDanmar Products, Inc.20030

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?

  • Of its descendants, K090341 (Danmar Products, Inc., 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MVA devices

MVA Orthosis, Cranial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MVA

1in 2024

2007: 22010: 12011: 32014: 32018: 12021: 22022: 32023: 22024: 1
2007high 3 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MVA

209in 2022

2011: 104 days median2014: 114 days median2022: 209 days median
2007high 209 (2022) · low 104 (2011)2026

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

2008: 12009: 12010: 22015: 12016: 12017: 32022: 1
2007high 3 (2017) · low 0 (2007)2025

MAUDE reports naming product code MVA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20080—01
20090—01
20101—02
2011310400
20120—00
20130—00
2014311400
20150—01
20160—01
20170—03
20181—00
20190—00
20200—00
20212—00
2022320901
20232—00
20241—00
20250—00
20260—0—

More from Danmar Products, Inc.

3 FDA decisions under this applicant name. See the company

  • K090341Michigan Cranial Reshaping OrthosisDanmar Products, Inc. · 2010
  • K013452Danmar Products Cranial Adjustive ProsthesisDanmar Products, Inc. · 2003

Recent decisions in MVA

The MVA category page

  • K241957Talee, Talee PostOpInvent Medical USA, LLC · 2024
  • K230444Talee, Talee PostOpInvent Medical USA, LLC · 2023
  • K223238STARband 3DOrthomerica Products, Inc. · 2023
  • K220681Talee, Talee PostOPInvent Medical USA, LLC · 2022
  • K203134Hanger Cranial Band 3DSymbion Logistics, LLC · 2022

https://510kreport.com/device/K003630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003630: Danmar Products Michigan Cranial Helmet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003630

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026