510(k) · Cleared
Recalled · Class II · 2025Phasor Drill
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotex, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Dec 1, 2016 as substantially equivalent to K014060 (Microaire Surgical Instruments, Inc., 2002) and 1 other predicate after a 164-day review. Its family tree reaches back 6 generations to 1993. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 1, 2016
- Review
- 164 days
- Class
- Class II
- Product code
- HBE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K931783 (1993). 14 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 5 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 4 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 3 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 2 generations backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- 1 generation backK014060 Microaire 1000E SystemMicroaire Surgical Instruments, Inc. · 2002
- This deviceK161704 Phasor DrillBiotex, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK230619 Hubly Electric Drill (H100)Hubly, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252696 LegacyPhasor Health, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK250815 Hubly Drill (H100)Hubly, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252060 GREENPhasor Health, LLC · 2025
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −5 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −4 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −3 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −2 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| −1 | K014060 | Microaire 1000E System | Microaire Surgical Instruments, Inc. | 2002 | — |
| 0 (this device) | K161704 | Phasor Drill | Biotex, Inc. | 2016 | — |
| +1 | K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | 2023 | — |
| +1 | K252696 | Legacy | Phasor Health, LLC | 2025 | — |
| +2 | K250815 | Hubly Drill (H100) | Hubly, Inc. | 2025 | — |
| +1 | K252060 | GREEN | Phasor Health, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
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 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014060 | Microaire 1000E SystemSummary page 4…r 1, 2016 Classification Regulation: 21 CFR 882.4310 Panel: Neurological Product Code: HBE Predicate Device K014060- MicroAire®1000E System MicroAire® Surgical Instruments K962913- Sterile D… | 2002 |
| * | K962913 | Synthes Sterile Drill BitsSummary page 4…Code: HBE Predicate Device K014060- MicroAire®1000E System MicroAire® Surgical Instruments K962913- Sterile Drill Bits Synthes, Inc. Indication for Use The Phasor Drill is a sterile, single-us… | 1996 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2025 | Class II | Z-2192-2025 | Process change control | Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K230619 (Hubly, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K014060.
How does its category compare?
All HBE devicesHBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
MAUDE reports naming product code HBE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 14 |
| 2008 | 2 | — | 47 | 14 |
| 2009 | 0 | — | 7 | 242 |
| 2010 | 0 | — | 23 | 492 |
| 2011 | 2 | — | 1 | 1,013 |
| 2012 | 1 | — | 26 | 1,146 |
| 2013 | 1 | — | 4 | 1,583 |
| 2014 | 2 | — | 0 | 559 |
| 2015 | 3 | 155 | 0 | 483 |
| 2016 | 2 | — | 7 | 848 |
| 2017 | 2 | — | 3 | 848 |
| 2018 | 2 | — | 0 | 787 |
| 2019 | 5 | 133 | 0 | 836 |
| 2020 | 0 | — | 0 | 1,025 |
| 2021 | 6 | 193 | 1 | 1,047 |
| 2022 | 2 | — | 0 | 900 |
| 2023 | 2 | — | 3 | 948 |
| 2024 | 0 | — | 1 | 1,153 |
| 2025 | 6 | 30 | 0 | 1,924 |
| 2026 | 1 | — | 19 | — |
What is it indicated for?
The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161704: Phasor Drill.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161704
Report an extraction error
Are you the manufacturer?
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