510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)

K253627510(k) TraditionalCleared Mar 26, 2026127-day reviewClass II21 CFR 882.4310Recalls 11

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

Surgify Medical OY · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

Cleared on Mar 26, 2026 as substantially equivalent to K251433 (Surgify Medical OY, 2025) after a 127-day review. Its family tree reaches back 11 generations to 1986. It has been recalled 11 times.

Decided
Mar 26, 2026
Review
127 days
Class
Class II
Product code
HBE
Recalls
11
Predicates
1

Its longest line of descent runs back 11 generations to K862807 (1986). 40 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2002: 1 other ancestor1992: 1 other ancestor2008: 2 other ancestors2004: 3 other ancestors2001: 3 other ancestors2000: 2 other ancestors1999: 1 other ancestor1998: 2 other ancestors1994: 4 other ancestors1997: 1 other ancestor1995: 5 other ancestors1986: 1 other ancestor1996: 1 other ancestor1985: 1 other ancestorK862807 · Treace Drill System · Treace Medical, Inc. · 1986×2: 2 generations cleared close together, K964548 (1997), K971059 (1997) K981637 · Integrated Drive/Pump System for Otolaryngology · Linvatec Corp. · 1998K990524 · E9000 System · Linvatec Corp. · 1999K012456 · Sodem High Speed System (Electric) (Ear, Nose, and Throat) · Sodemsystems · 2001K081475 · Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] · Medtronic Xomed, Inc. · 2008 · recalledK130755 · Hicut Highspeed Instrument · Adeor Medical AG · 2014K232684 · Surgify Halo · Surgify Medical OY · 2023×2: 2 generations cleared close together, K250380 (2025), K251433 (2025) 1990200020102020
Other ancestors, by generation 5 generations back: 3 other ancestors6 generations back: 9 other ancestors7 generations back: 8 other ancestors8 generations back: 2 other ancestors9 generations back: 5 other ancestors10 generations back: 2 other ancestors K251433 · Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) · Surgify Medical OY · 2025 · recalledK250380 · Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) · Surgify Medical OY · 2025 · recalledK232684 · Surgify Halo · Surgify Medical OY · 2023K130755 · Hicut Highspeed Instrument · Adeor Medical AG · 2014K081475 · Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)] · Medtronic Xomed, Inc. · 2008 · recalledK012456 · Sodem High Speed System (Electric) (Ear, Nose, and Throat) · Sodemsystems · 2001K990524 · E9000 System · Linvatec Corp. · 1999K981637 · Integrated Drive/Pump System for Otolaryngology · Linvatec Corp. · 1998K971059 · Universal Drive System · Linvatec Corp. · 1997K964548 · Apex Universal Drive System · Linvatec Corp. · 1997K862807 · Treace Drill System · Treace Medical, Inc. · 1986−10−50
  1. Root · 11 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
  2. 7 generations between
  3. 3 generations backK232684 Surgify HaloSurgify Medical OY · 2023
  4. 2 generations backK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
  5. 1 generation backK251433 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
  6. This deviceK253627 Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify…Surgify Medical OY · 2026
Show all 11 generations
  1. Root · 11 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
  2. 10 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
  3. 9 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
  4. 8 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
  5. 7 generations backK990524 E9000 SystemLinvatec Corp. · 1999
  6. 6 generations backK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
  7. 5 generations backK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
  8. 4 generations backK130755 Hicut Highspeed InstrumentAdeor Medical AG · 2014
  9. 3 generations backK232684 Surgify HaloSurgify Medical OY · 2023
  10. 2 generations backK250380 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
  11. 1 generation backK251433 Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify…Surgify Medical OY · 2025 · Recalled
  12. This deviceK253627 Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify…Surgify Medical OY · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K862807Treace Drill SystemTreace Medical, Inc.1986—
−10K964548Apex Universal Drive SystemLinvatec Corp.1997—
−9K971059Universal Drive SystemLinvatec Corp.1997—
−8K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp.1998—
−7K990524E9000 SystemLinvatec Corp.1999—
−6K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001—
−5K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc.20083
−4K130755Hicut Highspeed InstrumentAdeor Medical AG2014—
−3K232684Surgify HaloSurgify Medical OY2023—
−2K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY20255
−1K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…Surgify Medical OY20253
0 (this device)K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo…Surgify Medical OY2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198610
199210
199440
199550
199610
199710
199820
199910
200020
200130
200210
200430
200820
201110
FIG. 1 — Lineage of K253627, 1986–2026Source: 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 13.2 · 10 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? (1)

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
*K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo…
Summary page 5
…Device Class: Class II Classification Neurology Panel: II. Predicate Device Predicate Name and 510(k) Number: Surgify Halo, K251433. K253627 Page 2 of 4…
Surgify Medical OY20253

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 30, 2026Class IIZ-2565-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2557-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2559-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2556-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2569-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2555-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2571-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2563-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2567-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2573-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Apr 30, 2026Class IIZ-2561-2026Under Investigation by firmPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 40 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 9 of the 40 ancestors have a recall of any class.

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. 2026, this device’s year, is highlighted.

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?

Surgify Halo is a sterile surgical burr indicated for shaping and removal of hard tissue and bone in Neurosurgical, Spinal, ENT, and general surgical procedures.

Indications for use as stated in the FDA summary.

More from Surgify Medical OY

4 FDA decisions under this applicant name. See the company

  • 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
  • K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20255 recalls
  • K232684Surgify HaloSurgify Medical OY · 2023

Recent decisions in HBE

The HBE category page

  • 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
  • K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo…Surgify Medical OY · 20255 recalls

https://510kreport.com/device/K253627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K253627: Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253627

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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