510(k) · Cleared
ClearedBarron Rotary Blade Trephine Using Hessburg-Barron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Instruments, Inc. · HRH Trephine, Manual, Ophthalmic
Cleared on Jan 20, 1987 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it.
- Decided
- Jan 20, 1987
- Review
- 64 days
- Class
- Class I
- Product code
- HRH
- Recalls
- None
- Predicates
- 0
64 later devices descend from it, 3 citing it directly.
- This deviceK864520 Barron Rotary Blade Trephine Using Hessburg-BarronPrecision Instruments, Inc. · 1987
- Descendant · cites it directly · 61 of its ownK981063 Automated Corneal TrephineLaser Center Dev. Corp. · 1998
- Descendant · 2 generations on · 60 of its ownK041893 Intralase FS LaserIntra Lase Corp. · 2005
- Descendant · 3 generations on · 58 of its ownK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- Descendant · 4 generations on · 57 of its ownK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- Descendant · 4 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K981063Automated Corneal TrephineLaser Center Dev. Corp. · 1998 · cites it directly61descendants
- K041893Intralase FS LaserIntra Lase Corp. · 2005 · 2 generations on60descendants
- K060372Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006 · 3 generations on58descendants
- K063682Intralase Fusion LaserIntra Lase Corp. · 2007 · 4 generations on57descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 4 generations on56descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K864520 | Barron Rotary Blade Trephine Using Hessburg-Barron | Precision Instruments, Inc. | 1987 | — |
| +1 | K981063 | Automated Corneal Trephine | Laser Center Dev. Corp. | 1998 | — |
| +2 | K041893 | Intralase FS Laser | Intra Lase Corp. | 2005 | — |
| +3 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| +4 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| +4 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRH? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (64)
See all 643 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?
- Of its descendants, K981063 (Laser Center Dev. Corp., 1998) has gone furthest, with 61 descendants of its own.
How does its category compare?
All HRH devicesHRH Trephine, Manual, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRH
FDA has decided no HRH device since 2007.
Median 510(k) review, days · HRH
Too few HRH 510(k)s in any year since 2007 to give a median.
Recalls per year · HRH
No recall names HRH since 2007.
Adverse event reports per year · HRH
2in 2023
MAUDE reports naming product code HRH, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 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 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K864520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K864520: Barron Rotary Blade Trephine Using Hessburg-Barron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K864520
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026