510(k) · Cleared
ClearedMicroaire 1000E System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microaire Surgical Instruments, Inc. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Mar 5, 2002 as substantially equivalent to K991696 (Stryker Instruments, 1999) after an 85-day review. Its family tree reaches back 5 generations to 1993. 7 later devices descend from it.
- Decided
- Mar 5, 2002
- Review
- 85 days
- Class
- Class II
- Product code
- HBE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931783 (1993). 12 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 4 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 3 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 2 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 1 generation backK991696 Stryker Hermes-Ready Total Performance SystemStryker Instruments · 1999
- This deviceK014060 Microaire 1000E SystemMicroaire Surgical Instruments, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK161704 Phasor DrillBiotex, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 1 of its ownK230619 Hubly Electric Drill (H100)Hubly, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252696 LegacyPhasor Health, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK250815 Hubly Drill (H100)Hubly, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252060 GREENPhasor Health, LLC · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161704Phasor DrillBiotex, Inc. · 2016 · cites it directly4descendants
- K230619Hubly Electric Drill (H100)Hubly, Inc. · 2023 · 2 generations on1descendant
- K252696LegacyPhasor Health, LLC · 2025 · 2 generations on0descendants
- K250815Hubly Drill (H100)Hubly, Inc. · 2025 · 3 generations on0descendants
- K252060GREENPhasor Health, LLC · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −4 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −3 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −2 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −1 | K991696 | Stryker Hermes-Ready Total Performance System | Stryker Instruments | 1999 | — |
| 0 (this device) | K014060 | Microaire 1000E System | Microaire Surgical Instruments, Inc. | 2002 | — |
| +1 | K161704 | Phasor Drill | Biotex, Inc. | 2016 | 1 |
| +2 | K230619 | Hubly Electric Drill (H100) | Hubly, Inc. | 2023 | — |
| +2 | K252696 | Legacy | Phasor Health, LLC | 2025 | — |
| +3 | K250815 | Hubly Drill (H100) | Hubly, Inc. | 2025 | — |
| +2 | 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 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991696 | Stryker Hermes-Ready Total Performance SystemSummary page 1…eir accessories (21 CFR § 882.4310) The MicroAire® 1000E System is substantially equivalent to the Stryker® HERMES—Ready™ Total Performance System (TPS™), 510(k) number K991696, predicate device. Although the 1000E system does not integrate irrigation, joint shaving and endoscopy features, the intended us… | 1999 |
What descends from it? (7)
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)
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 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K161704 (Biotex, Inc., 2016) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K991696.
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.
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 MicroAire® 1000E System is indicated for use in cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and other bone related tissue in a variety surgical procedures. The applications include ENT, maxilliofacial, neurological, oral, orthopedic, plastic, podiatric and spinal surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014060 · printed Nov 4, 2026
Cite this page
510(k) Report. “K014060: Microaire 1000E System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014060
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026