510(k) · Cleared

Cleared

Rigid Gas Permeable Contact Lens

K013762510(k) TraditionalCleared Apr 3, 2002141-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

Bausch & Lomb, Incorporated · HQD Lens, Contact (Other Material) - Daily

Cleared on Apr 3, 2002 after a 141-day review; its predicate, P820065, is listed below. 15 later devices descend from it.

Decided: Apr 3, 2002
Review: 141 days
Class: Class II
Product code: HQD
Recalls: None
Predicates: 1

1 ancestor in all. 15 later devices descend from it, 3 citing it directly.

This deviceK013762 Rigid Gas Permeable Contact LensBausch & Lomb, Incorporated · 2002
Descendant · cites it directly · 14 of its ownK071043 Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES…Bausch & Lomb, Inc. · 2007 · Recalled
Descendant · 2 generations on · 9 of its ownK162005 Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2016
Descendant · 3 generations on · 7 of its ownK201194 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2020
Descendant · 4 generations on · 6 of its ownK203571 Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021
Descendant · cites it directly · 5 of its ownK183167 Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO…Bausch & Lomb, Incorporated · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2007high 5 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 15 · See all

K071043Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas…Bausch & Lomb, Inc. · 2007 · cites it directly14descendants
K162005Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2016 · 2 generations on9descendants
K201194Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2020 · 3 generations on7descendants
K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · 4 generations on6descendants
K183167Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…Bausch & Lomb, Incorporated · 2019 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013762	Rigid Gas Permeable Contact Lens	Bausch & Lomb, Incorporated	2002	—
+1	K071043	Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a)…	Bausch & Lomb, Inc.	2007	2
+2	K162005	Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2016	—
+3	K201194	Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2020	—
+4	K203571	Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens	Acuity Polymers, Inc.	2021	—
+1	K183167	Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO…	Bausch & Lomb, Incorporated	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2011	1	0
2016	1	0
2018	1	0
2019	1	0
2020	1	0
2021	2	0
2023	1	0
2024	5	0

FIG. 1 — Lineage of K013762, 2002–2024Source: 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 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? (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	Applicant	Decided	Recalls
*	P820065	Boston Lens (R) Lens - Clear FDA lists this PMA only through its supplements; the earliest we hold is P820065/S001 (Dec 23, 1983). Summary page 1 …O (hexafocon A) Rigid Gas Permeable Contact Lenses 3. PREDICATE DEVICE The BOSTON?® \|l (itafocon A) Rigid Gas Permeable Contact Lens approved in Premarket Application, P820065, on November 17, 1983, has been selected as the predicate device for the BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B), an…	Polymer Technology Corp.		—

Also cleared against P820065: 1 other device →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K071043	Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas…	Bausch & Lomb, Inc.	2007	14
K183167	Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…	Bausch & Lomb, Incorporated	2019	5
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, K071043 (Bausch & Lomb, Inc., 2007) has gone furthest, with 14 descendants of its own.
1 other device also cites its predicate P820065.

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 BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

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/K013762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013762: Rigid Gas Permeable Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013762

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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