510(k) · Cleared
ClearedAppasamy Slit Lamp, A1A-11 and A1A-12 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Appasamy Associates · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Jul 31, 2008 as substantially equivalent to K953030 (Naveen Intl., Inc., 1995) and 3 other predicates after a 14-day review. Its family tree reaches back 1 generation to 1990. 7 later devices descend from it.
- Decided
- Jul 31, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K900476 (1990). 4 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK900476 Woodlyn Slit Lamp Model HR-1Woodlyn, Inc. · 1990
- This deviceK082031 Appasamy Slit Lamp, A1A-11 and A1A-12 SeriesAppasamy Associates · 2008
- Descendant · cites it directly · 5 of its ownK110129 Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC · 2011
- Descendant · 2 generations on · 4 of its ownK133476 Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG · 2014
- Descendant · 3 generations on · 1 of its ownK162684 SL 220Carl Zeiss Meditec, AG · 2017
- Descendant · 4 generations on · 0 of its ownK253834 Visuref 600Carl Zeiss Vision GmbH · 2026
- Descendant · 3 generations on · 0 of its ownK163564 Slit Lamp SL-2000Nidek Co., Ltd. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110129Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC · 2011 · cites it directly5descendants
- K133476Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG · 2014 · 2 generations on4descendants
- K162684SL 220Carl Zeiss Meditec, AG · 2017 · 3 generations on1descendant
- K253834Visuref 600Carl Zeiss Vision GmbH · 2026 · 4 generations on0descendants
- K163564Slit Lamp SL-2000Nidek Co., Ltd. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900476 | Woodlyn Slit Lamp Model HR-1 | Woodlyn, Inc. | 1990 | — |
| 0 (this device) | K082031 | Appasamy Slit Lamp, A1A-11 and A1A-12 Series | Appasamy Associates | 2008 | — |
| +1 | K110129 | Righton Zoom Slit Lamp Microscope with Photo Option | Rightmedical Products, LLC | 2011 | — |
| +2 | K133476 | Slit Lamps with SL Cam 5.0 Digital Imaging Solution | Carl Zeiss Meditec, AG | 2014 | — |
| +3 | K162684 | SL 220 | Carl Zeiss Meditec, AG | 2017 | — |
| +4 | K253834 | Visuref 600 | Carl Zeiss Vision GmbH | 2026 | — |
| +3 | K163564 | Slit Lamp SL-2000 | Nidek Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 4 | 0 |
| 2026 | 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 HJO? 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 HJO device
- #1 K253834 Visuref 600score 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K953030 | Slit Lamp Aia 11Summary page 3…mps are substantially Equivalence to the following Predicate device: I. Company: Naveen Intl, Inc Model: AIA - 11 Slit Lamp 510(K) No.: K953030 II. Company: CSOS.R.L Model: SL 990 Slit Lamp 510(K) No.: K992836 III. Company: Woodlyn Inc… | 1995 |
| * | K992836 | SL990, SL980, SL950Summary page 3…aveen Intl, Inc Model: AIA - 11 Slit Lamp 510(K) No.: K953030 II. Company: CSOS.R.L Model: SL 990 Slit Lamp 510(K) No.: K992836 III. Company: Woodlyn Inc Model: Woodlyn HR-I Slit Lamp 510(K) No.: K900476 b) Appasamy AIA-1… | 1999 |
| * | K900476 | Woodlyn Slit Lamp Model HR-1Summary page 3…R.L Model: SL 990 Slit Lamp 510(K) No.: K992836 III. Company: Woodlyn Inc Model: Woodlyn HR-I Slit Lamp 510(K) No.: K900476 b) Appasamy AIA-12 Series Slit Lamps are substantially Equivalence to the following Predicate device: i. Co… | 1990 |
| * | K063750 | Xcel 255 Slit LampSummary page 3…ubstantially Equivalence to the following Predicate device: i. Company: Reichert, Inc Model: Xcel 255 Slit Lamp 510(K) No.: K063750 15. Summary of Technological Characteristics: Comparisons of technological characteristics of the Appasamy Slit Lamps with… | 2006 |
What descends from it? (7)
2 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?
- None of the 4 ancestors has a recall.
- Of its descendants, K110129 (Rightmedical Products, LLC, 2011) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HJO devicesHJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HJO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HJO
232in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HJO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJO
20in 2025
MAUDE reports naming product code HJO, 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 | — | 0 | 1 |
| 2008 | 4 | 117 | 0 | 3 |
| 2009 | 3 | 91 | 0 | 3 |
| 2010 | 5 | 121 | 0 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 2 | — | 2 | 16 |
| 2014 | 10 | 196 | 0 | 4 |
| 2015 | 2 | — | 2 | 8 |
| 2016 | 5 | 243 | 0 | 15 |
| 2017 | 9 | 232 | 0 | 15 |
| 2018 | 2 | — | 1 | 11 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Slit Lamp AIA-i1 Series and ALA-12 Series are intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082031: Appasamy Slit Lamp, A1A-11 and A1A-12 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082031
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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