510(k) Report

510(k) · Cleared

Cleared

Medicon Vipair High Speed System

K042974510(k) TraditionalCleared Jan 13, 200577-day reviewClass II21 CFR 882.4370

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

Medicon EG · HBB Motor, Drill, Pneumatic

Cleared on Jan 13, 2005 as substantially equivalent to K013091 (Von Zeppelin GmbH, 2002) and 5 other predicates after a 77-day review. Its family tree reaches back 3 generations to 1997.

Decided
Jan 13, 2005
Review
77 days
Class
Class II
Product code
HBB
Recalls
None
Predicates
9

Its longest line of descent runs back 3 generations to K973736 (1997). 8 ancestors in all, the oldest K922299 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors1999: 1 other ancestor1997: 1 other ancestor1992: 1 other ancestorK973736 · Aesculap Hilan Motor System · Aesculap, Inc. · 1997K980686 · Aesculap Hilan Motor System · Aesculap, Inc. · 1998K013091 · ZMM 2000 Zeppelin Millennium Motordrill System · Von Zeppelin GmbH · 20021990199520002005
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor K013091 · ZMM 2000 Zeppelin Millennium Motordrill System · Von Zeppelin GmbH · 2002K980686 · Aesculap Hilan Motor System · Aesculap, Inc. · 1998K973736 · Aesculap Hilan Motor System · Aesculap, Inc. · 19970
  1. Root · 3 generations backK973736 Aesculap Hilan Motor SystemAesculap, Inc. · 1997
  2. 2 generations backK980686 Aesculap Hilan Motor SystemAesculap, Inc. · 1998
  3. 1 generation backK013091 ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH · 2002
  4. This deviceK042974 Medicon Vipair High Speed SystemMedicon EG · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K973736Aesculap Hilan Motor SystemAesculap, Inc.1997—
−2K980686Aesculap Hilan Motor SystemAesculap, Inc.1998—
−1K013091ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH2002—
0 (this device)K042974Medicon Vipair High Speed SystemMedicon EG2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199710
199910
200220
FIG. 1 — Lineage of K042974, 1997–2005Source: 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), 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 HBB? 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 HBB device

  1. #1 K253772 Velocity Alpha MR High Speed Surgical Drill…score 11.0 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against? (9)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K013091ZMM 2000 Zeppelin Millennium Motordrill System
Summary page 2
….92(a)(3)] The Medicon High Speed Systems claims equivalence to the following system: Zeppelin ZMM 200 Millenium Motordrill System (K013091) Zeppelin Motordrill System (K92229) Aesculap HiLan Motor System for Neurosurgery (K980686)…
Von Zeppelin GmbH2002—
Kept off the family treeK092229FDA’s K092229 is Thyretain TM Tsi Reporter Bioassay
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Diagnostic Hybrids, Inc.2010—
*K980686Aesculap Hilan Motor System
Summary page 2
…Zeppelin ZMM 200 Millenium Motordrill System (K013091) Zeppelin Motordrill System (K92229) Aesculap HiLan Motor System for Neurosurgery (K980686) Komet Medical Xk - 95 Perforator Motor (K991625) Midas Rex Legend System (K020069) Midas…
Aesculap, Inc.1998—
*K991625Komet XK-95 Perforator Motor (MI-102)
Summary page 2
…Zeppelin Motordrill System (K92229) Aesculap HiLan Motor System for Neurosurgery (K980686) Komet Medical Xk - 95 Perforator Motor (K991625) Midas Rex Legend System (K020069) Midas Rex, Midas Rex I, II (K950518) Sodem Powered Surg…
Komet Medical1999—
*K020069Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend…
Summary page 2
…) Aesculap HiLan Motor System for Neurosurgery (K980686) Komet Medical Xk - 95 Perforator Motor (K991625) Midas Rex Legend System (K020069) Midas Rex, Midas Rex I, II (K950518) Sodem Powered Surgical Drill (K023066) Black Max by…
Medtronic Midas Rex20029
Kept off the family treeK950518FDA’s K950518 is Miele G 7781 Dental Thermal Disinfector
Our reading of the summary gave K950518, FDA’s number for Miele G 7781 Dental Thermal Disinfector (Miele Professional). Its FDA name has none of the distinctive words the summary uses for the device it names, “Midas Rex, Midas Rex I, II”. Kept off the family tree.
Summary page 2
…rosurgery (K980686) Komet Medical Xk - 95 Perforator Motor (K991625) Midas Rex Legend System (K020069) Midas Rex, Midas Rex I, II (K950518) Sodem Powered Surgical Drill (K023066) Black Max by Anspach (K930660) Micromax by Anspach…
Miele Professional1996—
*K023066Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic)
Summary page 2
…95 Perforator Motor (K991625) Midas Rex Legend System (K020069) Midas Rex, Midas Rex I, II (K950518) Sodem Powered Surgical Drill (K023066) Black Max by Anspach (K930660) Micromax by Anspach (K965080) 2.6 Device Describtion [807.92(a…
Sodemsystems2002—
Kept off the family treeK930660FDA’s K930660 is Creatine Kinase (CK) Reagent Set
Our reading of the summary gave K930660, FDA’s number for Creatine Kinase (CK) Reagent Set (Pointe Scientific, Inc.,). Its FDA name has none of the distinctive words the summary uses for the device it names, “Black Max by Anspach”. Kept off the family tree.
Summary page 2
…idas Rex Legend System (K020069) Midas Rex, Midas Rex I, II (K950518) Sodem Powered Surgical Drill (K023066) Black Max by Anspach (K930660) Micromax by Anspach (K965080) 2.6 Device Describtion [807.92(a)(4)] The Medicon VIPAIR pneuma…
Pointe Scientific, Inc.,1993—
*K965080Anspach Micromax System
Summary page 2
…Midas Rex, Midas Rex I, II (K950518) Sodem Powered Surgical Drill (K023066) Black Max by Anspach (K930660) Micromax by Anspach (K965080) 2.6 Device Describtion [807.92(a)(4)] The Medicon VIPAIR pneumatic high speed system is specially designed…
The Anspach Effort, Inc.199711

Also cleared against K013091: 1 other device →

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 8 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • 1 other device also cites its predicate K013091.

How does its category compare?

All HBB devices

HBB Motor, Drill, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBB

1in 2018

2007: 12009: 12010: 22015: 12017: 12018: 12026 (partial year): 1
2007high 2 (2010) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBB

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

Recalls per year · HBB

2in 2025

2007: 12008: 12009: 12013: 12015: 12017: 12025: 2
2007high 2 (2025) · low 0 (2010)2026

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

Adverse event reports per year · HBB

1,016in 2025

2007: 822008: 1762009: 1962010: 1832011: 3992012: 3792013: 6852014: 5622015: 4402016: 2732017: 2032018: 2952019: 2842020: 2632021: 2602022: 1722023: 1802024: 7592025: 1,016
2007high 1,016 (2025) · low 82 (2007)2025

MAUDE reports naming product code HBB, 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
20071—182
20080—1176
20091—1196
20102—0183
20110—0399
20120—0379
20130—1685
20140—0562
20151—1440
20160—0273
20171—1203
20181—0295
20190—0284
20200—0263
20210—0260
20220—0172
20230—0180
20240—0759
20250—21,016
20261—0—

What is it indicated for?

The Medicon VIPAIR high speed system is specially designed for cutting and drilling of cranial and spinal bones in the Neurology. Thanks to a wide variety of working attachments and tools, the Medicon pneumatic high speed system "VIPAIR" can be also used in the ENT and Orthopaedics.

The Medicon VIPAIR high speed system are intended for use and handling by professional and qualified Neurology, ENT or Orthopaedic surgeons.

Indications for use as stated in the FDA summary.

Also cleared against K013091

1 other device cites the same predicate.

  • K130755Hicut Highspeed InstrumentAdeor Medical AG · 2014

More from Medicon EG

17 FDA decisions under this applicant name. See the company

  • K161680MEDICON Spinal Spreading SystemsMedicon EG · 2017
  • K100916Medicon Mogen ClampMedicon EG · 2010
  • K083803Fixit Headrest Clamp SystemMedicon EG · 2010
  • K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG · 2006
  • K050478Medicon Imf-Orion ScrewsMedicon EG · 2005

Recent decisions in HBB

The HBB category page

  • K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AG · 2026
  • K172907ELAN 4 Air Motor SystemAesculap, Inc. · 20182 recalls
  • K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic…Medtronic Powered Surgical Solutions · 2017
  • K150801Stryker Maestro Air MotorsStryker Corporation · 20151 recall
  • K101168Legend Power Adapter Model: 6475000Medtronic Sofamor Danek · 2010

https://510kreport.com/device/K042974 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042974: Medicon Vipair High Speed System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042974

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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