510(k) · Cleared
ClearedHM-Lamp II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hillusa, Inc. · FTD Lamp, Surgical
Cleared on Jul 8, 2010 as substantially equivalent to K003423 (St. Francis Medical Equipment Co., Ltd., 2001) after a 163-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jul 8, 2010
- Review
- 163 days
- Class
- Class II
- Product code
- FTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003423 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003423 ST. Francis Operating Theatre Lamp, Models OLH01-125 and LC-055St. Francis Medical Equipment Co., Ltd. · 2001
- This deviceK100234 HM-Lamp IIHillusa, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003423 | ST. Francis Operating Theatre Lamp, Models OLH01-125 and LC-055 | St. Francis Medical Equipment Co., Ltd. | 2001 | — |
| 0 (this device) | K100234 | HM-Lamp II | Hillusa, Inc. | 2010 | — |
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 FTD? 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 |
|---|---|---|---|
| * | K003423 | ST. Francis Operating Theatre Lamp, Models OLH01-125 and LC-055Summary page 1…II Classification number: FTD, Regulation # 878.4580 3. Predicate Device Information: ST. FRANCIS OPERATING THEATRE LAMPS, K003423. ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. P.O. BOX 129, SHIEN CHUANG 24299. TAIPEI SHIEN, TAIWAN, R.OC. 4. Device D… | 2001 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FTD devicesFTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FTD
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FTD
70in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTD
6in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTD
81in 2025
MAUDE reports naming product code FTD, 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 | 1 | — | 11 | 7 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 9 | 22 |
| 2010 | 2 | — | 3 | 21 |
| 2011 | 1 | — | 0 | 30 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 3 | 70 | 0 | 29 |
| 2014 | 0 | — | 0 | 29 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 1 | 18 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 80 |
| 2020 | 0 | — | 0 | 105 |
| 2021 | 0 | — | 0 | 65 |
| 2022 | 0 | — | 0 | 136 |
| 2023 | 0 | — | 6 | 251 |
| 2024 | 0 | — | 0 | 144 |
| 2025 | 0 | — | 0 | 81 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HM-LAMP II is a device intended to be used to provide visible illumination of the surgical field or the patient. They are designed for minor surgical procedures.
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/K100234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100234: HM-Lamp II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100234
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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