510(k) Report

510(k) · Cleared

Cleared

Craniocut

K022942510(k) TraditionalCleared Oct 21, 200246-day reviewClass II21 CFR 882.4310

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

Aesculap, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Cleared on Oct 21, 2002 as substantially equivalent to K980686 (Aesculap, Inc., 1998) and 6 other predicates after a 46-day review. Its family tree reaches back 6 generations to 1993.

Decided
Oct 21, 2002
Review
46 days
Class
Class II
Product code
HBE
Recalls
None
Predicates
7

Its longest line of descent runs back 6 generations to K931783 (1993). 20 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 2 other ancestors2000: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestor1995: 1 other ancestor1994: 4 other ancestors1996: 1 other ancestorK931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996K973700 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1998K980787 · Hermes Operating Room Control Center with the Wom 20L Insufflator · Computer Motion, Inc. · 1998K991696 · Stryker Hermes-Ready Total Performance System · Stryker Instruments · 1999K014060 · Microaire 1000E System · Microaire Surgical Instruments, Inc. · 200219901992199419961998200020022004
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 1 other ancestor3 generations back: 5 other ancestors4 generations back: 2 other ancestors K014060 · Microaire 1000E System · Microaire Surgical Instruments, Inc. · 2002K991696 · Stryker Hermes-Ready Total Performance System · Stryker Instruments · 1999K980787 · Hermes Operating Room Control Center with the Wom 20L Insufflator · Computer Motion, Inc. · 1998K973700 · Hermes Operating Room Control Center · Computer Motion, Inc. · 1998K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996K931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993−50
  1. Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
  3. 4 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
  4. 3 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
  5. 2 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
  6. 1 generation backK014060 Microaire 1000E SystemMicroaire Surgical Instruments, Inc. · 2002
  7. This deviceK022942 CraniocutAesculap, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K931783Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc.1993—
−5K960655Aesop System and AccessoriesComputer Motion, Inc.1996—
−4K973700Hermes Operating Room Control CenterComputer Motion, Inc.1998—
−3K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998—
−2K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments1999—
−1K014060Microaire 1000E SystemMicroaire Surgical Instruments, Inc.2002—
0 (this device)K022942CraniocutAesculap, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199440
199510
199610
199710
199820
199910
200010
200120
200210
FIG. 1 — Lineage of K022942, 1993–2002Source: 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 HBE? 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 HBE device

  1. #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.1 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K980686Aesculap Hilan Motor System
Summary page 1
…ocut described in this premarket notification is substantially equivalent to these predicate devices : 0 Aesculap HiLan Motor System for Neurology (K980686) 0 Aesculap Microspeed EC Motorsystem (KO03612) 0 MicroAire 1OOOE System (K014060)…
Aesculap, Inc.1998—
*K003612Microspeed EC Motorsystem GD650/GD653Aesculap, Inc.2001—
*K014060Microaire 1000E System
Summary page 1
…Aesculap HiLan Motor System for Neurology (K980686) 0 Aesculap Microspeed EC Motorsystem (KO03612) 0 MicroAire 1OOOE System (K014060) Komet XK095 High Speed Drill System (K984035) 0 Anspach Angled Micronose Attachmen…
Microaire Surgical Instruments, Inc.2002—
*K984035XK-95 High Speed Motor Drill System
Summary page 1
…0 Aesculap Microspeed EC Motorsystem (KO03612) 0 MicroAire 1OOOE System (K014060) Komet XK095 High Speed Drill System (K984035) 0 Anspach Angled Micronose Attachment (K002903) 0 Anspach eMax Drill System (KO1 144…
Komet Medical1999—
*K002903Anspach Angled Micronose Attachment
Summary page 1
…0 MicroAire 1OOOE System (K014060) Komet XK095 High Speed Drill System (K984035) 0 Anspach Angled Micronose Attachment (K002903) 0 Anspach eMax Drill System (KO1 1444) 0 Midas Rex Legend System (K020069)…
The Anspach Effort, Inc.20001
*K011444Anspach Emax Drill SystemThe Anspach Effort, Inc.200170
*K020069Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend…
Summary page 1
…0 Anspach Angled Micronose Attachment (K002903) 0 Anspach eMax Drill System (KO1 1444) 0 Midas Rex Legend System (K020069) 4 { a 6 4 ,.* ''XCl,…
Medtronic Midas Rex20029

Also cleared against K980686: 3 other devices →

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 9 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
  • 5 of the 20 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K980686.

How does its category compare?

All HBE devices

HBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBE

6in 2025

2007: 22008: 22011: 22012: 12013: 12014: 22015: 32016: 22017: 22018: 22019: 52021: 62022: 22023: 22025: 62026 (partial year): 1
2007high 6 (2021) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBE

30in 2025

2015: 155 days median2019: 133 days median2021: 193 days median2025: 30 days median
2007high 193 (2021) · low 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HBE

1in 2024

2008: 472009: 72010: 232011: 12012: 262013: 42016: 72017: 32021: 12023: 32024: 12026 (partial year): 19
2007high 47 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HBE

1,924in 2025

2007: 142008: 142009: 2422010: 4922011: 1,0132012: 1,1462013: 1,5832014: 5592015: 4832016: 8482017: 8482018: 7872019: 8362020: 1,0252021: 1,0472022: 9002023: 9482024: 1,1532025: 1,924
2007high 1,924 (2025) · low 14 (2007)2025

MAUDE reports naming product code HBE, 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—014
20082—4714
20090—7242
20100—23492
20112—11,013
20121—261,146
20131—41,583
20142—0559
201531550483
20162—7848
20172—3848
20182—0787
201951330836
20200—01,025
2021619311,047
20222—0900
20232—3948
20240—11,153
202563001,924
20261—19—

What is it indicated for?

Aesculap's Craniocut is intended for use in cutting bone in craniotomies.

Indications for use as stated in the FDA summary.

Also cleared against K980686

3 other devices cite the same predicate.

  • K062413Aesculap Pneumatic KerrisonAesculap, Inc. · 2006
  • K042974Medicon Vipair High Speed SystemMedicon EG · 2005
  • K013091ZMM 2000 Zeppelin Millennium Motordrill SystemVon Zeppelin GmbH · 2002

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

Recent decisions in HBE

The HBE category page

  • K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo…Surgify Medical OY · 202611 recalls
  • K250815Hubly Drill (H100)Hubly, Inc. · 2025
  • K252060GREENPhasor Health, LLC · 2025
  • K252662UniBurNakanishi, Inc. · 2025
  • K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20253 recalls

https://510kreport.com/device/K022942 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022942: Craniocut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022942

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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