510(k) · Cleared

Cleared

Rose K Post Graft Lens

K013646510(k) TraditionalCleared May 30, 2002206-day reviewClass II21 CFR 886.5916

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

Rose K International, Ltd. · HQD Lens, Contact (Other Material) - Daily

Cleared on May 30, 2002 after a 206-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 39 later devices descend from it.

Decided: May 30, 2002
Review: 206 days
Class: Class II
Product code: HQD
Recalls: None
Predicates: 0

39 later devices descend from it, 2 citing it directly.

This deviceK013646 Rose K Post Graft LensRose K International, Ltd. · 2002
Descendant · cites it directly · 38 of its ownK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
Descendant · 2 generations on · 26 of its ownK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
Descendant · 3 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
Descendant · 4 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
Descendant · 5 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2006high 6 (2016) · low 0 (2009)2026

Most influential descendants

Showing 5 of 39 · See all

K053124Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Bausch & Lomb, Incorporated · 2006 · cites it directly38descendants
K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · 2 generations on26descendants
K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · 3 generations on20descendants
K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · 4 generations on19descendants
K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · 5 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013646	Rose K Post Graft Lens	Rose K International, Ltd.	2002	—
+1	K053124	Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)…	Bausch & Lomb, Incorporated	2006	—
+2	K071266	Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens	Bausch & Lomb, Inc.	2007	2
+3	K153066	BostonSight IC Corneal Lens, BostonSight IC Scleral Lens	Boston Foundation For Sight	2016	—
+4	K161461	BostonSight PD Prosthetic Device	Bostonsight	2016	1
+5	K171404	BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)	Bausch + Lomb, Incorporated	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	3	0
2008	1	0
2011	2	0
2012	1	0
2016	6	0
2017	4	0
2018	3	0
2019	2	0
2020	1	0
2021	3	0
2022	3	0
2023	3	0
2024	5	0
2026	1	0

FIG. 1 — Lineage of K013646, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HQD? 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 HQD device

#1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (39)

See all 39

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053124	Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…	Bausch & Lomb, Incorporated	2006	38
K081443	Menicon Z Rigid Gas Permeable Contact Lens	Menicon Co, Ltd.	2008	1

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, K053124 (Bausch & Lomb, Incorporated, 2006) has gone furthest, with 38 descendants of its own.

How does its category compare?

All HQD devices

HQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQD

5in 2024

2007high 9 (2017) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQD

80in 2024

2007high 123 (2021) · low 29 (2022)2026

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

Recalls per year · HQD

1in 2010

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · HQD

2in 2025

2007high 26 (2014) · low 0 (2018)2025

MAUDE reports naming product code HQD, 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	4	78	0	6
2008	5	100	0	8
2009	2	—	0	12
2010	0	—	1	2
2011	2	—	0	7
2012	2	—	0	10
2013	0	—	0	15
2014	1	—	0	26
2015	0	—	0	5
2016	7	119	0	1
2017	9	66	0	3
2018	5	53	0	0
2019	2	—	0	5
2020	1	—	0	2
2021	3	123	0	3
2022	3	29	0	3
2023	3	77	0	8
2024	5	80	0	3
2025	0	—	0	2
2026	1	—	0	—

What is it indicated for?

The Rose K Post Graft Rigid Gas Permeable Contact Lens (hexafocon A) and Rose K Post Graft Rigid Gas Permeable Contact Lens (enflufocon B) are indicated for correction of refractive errors following penetrating keratoplasty in nonaphakic persons. The lenses may be disinfected by chemical methods.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013646 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013646: Rose K Post Graft Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013646

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026