510(k) · Cleared
ClearedHandX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Human Xtensions, Ltd. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Sep 13, 2021 as substantially equivalent to K173919 (Human Extension, Ltd., 2018) and 1 other predicate after a 60-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Sep 13, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K912544 (1991). 23 ancestors in all, the oldest K904578 (1990). No later device cites it as a predicate yet.
- Root · 6 generations backK912544 Bipolar ForcepsEverest Medical Corp. · 1991
- 5 generations backK972415 Minisite*Bipolar Forceps** DeviceUnited States Surgical, A Division of Tyco Healthc · 1997
- 4 generations backK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- 3 generations backK123102 Sovereign MiniAesculap, Inc. · 2013
- 2 generations backK173919 HX DeviceHuman Extension, Ltd. · 2018
- 1 generation backK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
- This deviceK212214 HandXHuman Xtensions, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K912544 | Bipolar Forceps | Everest Medical Corp. | 1991 | — |
| −5 | K972415 | Minisite*Bipolar Forceps** Device | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −4 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| −3 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| −2 | K173919 | HX Device | Human Extension, Ltd. | 2018 | — |
| −1 | K203603 | Monopolar Hook | Human Xtensions, Ltd. | 2021 | — |
| 0 (this device) | K212214 | HandX | Human Xtensions, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | K173919 | HX DeviceSummary page 4…Class II Regulation Number: 21 CFR 876.1500, 876.4400 Predicate Devices: HX Device, Human Xtensions (K173919) Monopolar Hook, Human Xtensions (K203603) Purpose of the Special 510(k) Notice T… | 2018 |
| * | K203603 | Monopolar HookSummary page 4…6.4400 Predicate Devices: HX Device, Human Xtensions (K173919) Monopolar Hook, Human Xtensions (K203603) Purpose of the Special 510(k) Notice The HandX is a modification to the prior versions of the device that were cleared under K… | 2021 |
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 30 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 23 ancestors have a recall of any class.
- 5 other devices also cite its predicate K173919.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212214: HandX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212214
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