510(k) · Cleared
ClearedRIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionime Corporation · QRL Multiple Use Blood Lancet For Single Patient Use Only
Cleared on Sep 26, 2022 as substantially equivalent to K113332 (ACON Laboratories, Inc., 2012) and 1 other predicate after a 168-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Sep 26, 2022
- Review
- 168 days
- Class
- Class II
- Product code
- QRL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002134 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- 3 generations backK090057 ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009
- 2 generations backK113332 ON Call Chosen Lancing DeviceACON Laboratories, Inc. · 2012
- 1 generation backK153670 Genteel Lancing DeviceGenteel, LLC · 2016
- This deviceK221062 RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing…Bionime Corporation · 2022
- Descendant · cites it directly · 0 of its ownK231797 Medifun Lancing Device, Model No. LD-E1Medifun Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K231797Medifun Lancing Device, Model No. LD-E1Medifun Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| −3 | K090057 | ON-Call Plus Blood Glucose Monitoring System | Acon Laboratories Co. | 2009 | — |
| −2 | K113332 | ON Call Chosen Lancing Device | ACON Laboratories, Inc. | 2012 | — |
| −1 | K153670 | Genteel Lancing Device | Genteel, LLC | 2016 | — |
| 0 (this device) | K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | Bionime Corporation | 2022 | — |
| +1 | K231797 | Medifun Lancing Device, Model No. LD-E1 | Medifun Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 QRL? 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 QRL device
- #1 K214022 Accu-Chek Softclix Blood Lancing Systemscore 38.9 · 1 generation · 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 |
|---|---|---|---|
| * | K113332 | ON Call Chosen Lancing DeviceSummary page 6…ature Product Code: FMK Regulation Number: 21 CFR 878.4850 510(k) Number: K113332 510(k) Submitter: ACON Laboratories Inc. Device Class: Class II… | 2012 |
| * | K153670 | Genteel Lancing DeviceSummary page 6…Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets 510(k) Number: K153670 510(k) Submitter: Genteel LLC Device Class: Class II… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231797 | Medifun Lancing Device, Model No. LD-E1 | 2023 | 0 |
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 22 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K231797 (Medifun Corporation, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K113332.
How does its category compare?
All QRL devicesQRL Multiple Use Blood Lancet For Single Patient Use Only: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QRL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QRL
155in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QRL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QRL
133in 2025
MAUDE reports naming product code QRL, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 17 | 91 | 0 | 1 |
| 2023 | 3 | 155 | 0 | 3 |
| 2024 | 2 | — | 0 | 7 |
| 2025 | 2 | — | 1 | 133 |
| 2026 | 3 | 54 | 0 | — |
What is it indicated for?
RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative…
Read the full statement (259 words)
RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
GE Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221062: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221062
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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