510(k) · Cleared
ClearedKahook Dual Blade Glide (KDB Glide)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New World Medical, Inc. · QUQ Knife, Intraocular Pressure Lowering
Cleared on May 17, 2024 as substantially equivalent to K040584 (Neomedix Corp., 2004) after a 781-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- May 17, 2024
- Review
- 781 days
- Class
- Class II
- Product code
- QUQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K792365 (1979). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK792365 Bipolar ForcepsConcept, Inc. · 1979
- 3 generations backK993655 Micro-France Electrosurgical Instruments, VariousXomed, Inc. · 1999 · Recalled
- 2 generations backK024304 Microsurgical Bipolar HandpieceNeomedix Corp. · 2003
- 1 generation backK040584 NMX-1000Neomedix Corp. · 2004
- This deviceK220891 Kahook Dual Blade Glide (KDB Glide)New World Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K792365 | Bipolar Forceps | Concept, Inc. | 1979 | — |
| −3 | K993655 | Micro-France Electrosurgical Instruments, Various | Xomed, Inc. | 1999 | 2 |
| −2 | K024304 | Microsurgical Bipolar Handpiece | Neomedix Corp. | 2003 | — |
| −1 | K040584 | NMX-1000 | Neomedix Corp. | 2004 | — |
| 0 (this device) | K220891 | Kahook Dual Blade Glide (KDB Glide) | New World Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 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 QUQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K040584 | NMX-1000Summary page 5…Knife Regulation Numbers 21 CFR 878.4400 Device Classification: Class II Predicate Device: NMX-1000™, NeoMedix Corporation (K040584) Reference Device: OMNI Surgical System, Sight Sciences, Inc. (K202678) III. DEVICE DESCRIPTION The Kahook… | 2004 |
| † | K202678 | OMNI Surgical System | 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 45 years and passes through 4 companies; a new generation was cleared every 20.0 years on median.
- 2 of the 17 ancestors have a recall of any class.
How does its category compare?
All QUQ devicesQUQ Knife, Intraocular Pressure Lowering: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QUQ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QUQ
Too few QUQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QUQ
No recall names QUQ since 2007.
Adverse event reports per year · QUQ
No MAUDE report names QUQ since 2007.
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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220891: Kahook Dual Blade Glide (KDB Glide).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220891
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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