510(k) Report

510(k) · Cleared

Cleared

Calvitron Hair Transplant System

K952737510(k) TraditionalCleared Oct 3, 1995110-day reviewClass I21 CFR 878.4800

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

Medicamat S.A. · GAH Stylet, Surgical, General & Plastic Surgery

Cleared on Oct 3, 1995 after a 110-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Oct 3, 1995
Review
110 days
Class
Class I
Product code
GAH
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2013: 2 descendants cleared2018: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952737 Calvitron Hair Transplant SystemMedicamat S.A. · 1995
  2. Descendant · cites it directly · 3 of its ownK103428 The Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2011
  3. Descendant · 2 generations on · 1 of its ownK123548 The Artas SystemRestoration Robotics, Inc. · 2013 · Recalled
  4. Descendant · 3 generations on · 0 of its ownK173358 ARTAS SystemRestoration Robotics, Inc. · 2018
  5. Descendant · 2 generations on · 0 of its ownK123154 Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2013

Most influential descendants

Showing 4 of 4 · See all
  • K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2011 · cites it directly3descendants
  • K123548The Artas SystemRestoration Robotics, Inc. · 2013 · 2 generations on1descendant
  • K173358ARTAS SystemRestoration Robotics, Inc. · 2018 · 3 generations on0descendants
  • K123154Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952737Calvitron Hair Transplant SystemMedicamat S.A.1995—
+1K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.2011—
+2K123548The Artas SystemRestoration Robotics, Inc.20134
+3K173358ARTAS SystemRestoration Robotics, Inc.2018—
+2K123154Artas System From Restoration RoboticsRestoration Robotics, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201810
FIG. 1 — Lineage of K952737, 1995–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 GAH? 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103428The Artas System From Restoration RoboticsRestoration Robotics, Inc.20113

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, K103428 (Restoration Robotics, Inc., 2011) has gone furthest, with 3 descendants of its own.

How does its category compare?

All GAH devices

GAH Stylet, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAH

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAH

Too few GAH 510(k)s in any year since 2007 to give a median.

Recalls per year · GAH

2in 2016

2016: 2
2007high 2 (2016) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GAH

10in 2025

2019: 32020: 12021: 22022: 72023: 82024: 22025: 10
2007high 10 (2025) · low 0 (2007)2025

MAUDE reports naming product code GAH, 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
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—20
20170—00
20180—00
20190—03
20200—01
20210—02
20220—07
20230—08
20240—02
20250—010
20260—0—

More from Medicamat S.A.

2 FDA decisions under this applicant name. See the company

  • K972148B.U.S. EndotronMedicamat S.A. · 1997

Recent decisions in GAH

The GAH category page

  • K110355Venx RevolutionVenx, LLC · 2011
  • K000932Arachnophlebectomy NeedleAdvanced Medical Products, Inc. · 2000
  • K970306Markman Template SystemBarry Markman, M.D. · 1997
  • K972918Rapid Fire Hair Implanter CarouselApex Medical Products, LLC · 1997
  • K972521Navigator (Stylet) 2006Sil-Med Corp. · 1997

https://510kreport.com/device/K952737 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952737: Calvitron Hair Transplant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952737

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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