510(k) · Cleared

Recalled · Class II · 2016

Optical Biometer AL-Scan

K133132510(k) TraditionalCleared Jun 11, 2014254-day reviewClass II21 CFR 886.1850Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nidek Co., Ltd. · HJO Biomicroscope, Slit-Lamp, Ac-Powered

Cleared on Jun 11, 2014 as substantially equivalent to K082891 (Haag-Streit AG, 2009) and 3 other predicates after a 254-day review. Its family tree reaches back 5 generations to 1996. It has been recalled once.

Decided: Jun 11, 2014
Review: 254 days
Class: Class II
Product code: HJO
Recalls: 1
Predicates: 4

Its longest line of descent runs back 5 generations to K955442 (1996). 23 ancestors in all, the oldest K781994 (1979). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
4 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
3 generations backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
2 generations backK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
1 generation backK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
This deviceK133132 Optical Biometer AL-ScanNidek Co., Ltd. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K955442	Kowa SC-1200 Photo Slit Lamp System	Kowa Optimed, Inc.	1996	—
−4	K991284	Anterior Eye-Segment Analysis System	Nidek, Inc.	1999	—
−3	K012873	Documenting Laser Slit Lamp, DP 2010	Bausch & Lomb, Inc.	2001	—
−2	K030393	Optical Low Coherence Reflectometry (Olcr) Pachymeter	Haag-Streit Holding AG	2003	—
−1	K082891	Lenstar, Model LS900	Haag-Streit AG	2009	3
0 (this device)	K133132	Optical Biometer AL-Scan	Nidek Co., Ltd.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1985	1	0
1986	1	0
1987	2	0
1990	2	0
1993	2	0
1994	2	0
1996	2	0
1997	1	0
2000	1	0
2002	1	0
2003	2	0

FIG. 1 — Lineage of K133132, 1996–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K082891	Lenstar, Model LS900 Summary page 1 …iomnicroscope Classification: 21 CFR §886.1850, Class 11 21 CFR §892.1560, Class 11 Product Code: HJO IYO PREDICATE DEVICE(S) * LenStar LS 900 (K082891) * PacScan 300 (K843696) " EchoScan Model US-1800 (K020876) * Pentacamt (K030719) 510(k) SUMMARY (…	Haag-Streit AG	2009	3
*	K843696	Ophthalmic a-Scan a-2000 Sonome Summary page 1 …ion: 21 CFR §886.1850, Class 11 21 CFR §892.1560, Class 11 Product Code: HJO IYO PREDICATE DEVICE(S) * LenStar LS 900 (K082891) * PacScan 300 (K843696) " EchoScan Model US-1800 (K020876) * Pentacamt (K030719) 510(k) SUMMARY (CONT.) INDICATIONS FOR USE O…	Sonomed Technology, Inc.	1985	—
*	K020876	Echoscan, Model US-1800 Summary page 1 …CFR §892.1560, Class 11 Product Code: HJO IYO PREDICATE DEVICE(S) * LenStar LS 900 (K082891) * PacScan 300 (K843696) " EchoScan Model US-1800 (K020876) * Pentacamt (K030719) 510(k) SUMMARY (CONT.) INDICATIONS FOR USE OPTICAL BIOMETER AL-Scan Indications for…	Nidek, Inc.	2002	—
*	K030719	Pentacam Scheimpflug Camera Summary page 1 …Product Code: HJO IYO PREDICATE DEVICE(S) * LenStar LS 900 (K082891) * PacScan 300 (K843696) " EchoScan Model US-1800 (K020876) * Pentacamt (K030719) 510(k) SUMMARY (CONT.) INDICATIONS FOR USE OPTICAL BIOMETER AL-Scan Indications for Use The OPTICAL BIOMETER AL…	Oculus Optikgerate GmbH	2003	1

Also cleared against K082891: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 1, 2016	Class II	Z-2587-2016	Software in the Use Environment	Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
3 of the 23 ancestors have a recall of any class.
4 other devices also cite its predicate K082891.

How does its category compare?

All HJO devices

HJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · HJO

1in 2024

2007high 10 (2014) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HJO

232in 2017

2007high 243 (2016) · low 91 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HJO

1in 2018

2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HJO

20in 2025

2007high 20 (2025) · low 1 (2007)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?

The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as:

* axial length;

* corneal thickness;

* anterior chamber depth;

* corneal curvature radii;

* corneal cylinder axis;

* white-to-white distance; and

* pupil diameter.

Axial length and corneal thickness can also be measured using ultrasound.

The OPTICAL BIOMETER AL-Scan also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133132 · printed Nov 4, 2026

Cite this page

510(k) Report. “K133132: Optical Biometer AL-Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133132

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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