510(k) · Cleared
ClearedInfinitech Bullet Endo Illuminated Pick Manipulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinitech, Inc. · HJM Transilluminator, Ac-Powered
Cleared on Oct 1, 1997 as substantially equivalent to K940393 (Peregrine Surgical, Ltd., 1994) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Oct 1, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- HJM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940392 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK940392 Peregrine Pic MinipulatorPeregrine Surgical, Ltd. · 1994
- This deviceK972506 Infinitech Bullet Endo Illuminated Pick ManipulatorInfinitech, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940392 | Peregrine Pic Minipulator | Peregrine Surgical, Ltd. | 1994 | — |
| 0 (this device) | K972506 | Infinitech Bullet Endo Illuminated Pick Manipulator | Infinitech, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 HJM? 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? (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 |
|---|---|---|---|
| * | K940393 | Peregrine Wide Angle Light PipeSummary page 1…d materials for ophthalmic surgical instruments and is configured in a common tool geometry. Predicate Devices: Peregrine Surgical Ltd. Peregrine Wide Angle Light Pipe (K940393) and Peregrine Pic Manipulator (K940392). Predicate Comparison: A chart comparing the Multi-Spot Adapter to the predicate device… | 1994 |
| * | K940392 | Peregrine Pic MinipulatorSummary page 1…ruments and is configured in a common tool geometry. Predicate Devices: Peregrine Surgical Ltd. Peregrine Wide Angle Light Pipe (K940393) and Peregrine Pic Manipulator (K940392). Predicate Comparison: A chart comparing the Multi-Spot Adapter to the predicate devices, demonstrating substantial equivalence… | 1994 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All HJM devicesHJM Transilluminator, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HJM
FDA has decided no HJM device since 2007.
Median 510(k) review, days · HJM
Too few HJM 510(k)s in any year since 2007 to give a median.
Recalls per year · HJM
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJM
1in 2016
MAUDE reports naming product code HJM, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 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 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pick Manipulator is a manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination.
There are no contraindications for the device.
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/K972506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972506: Infinitech Bullet Endo Illuminated Pick Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972506
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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