510(k) Report

510(k) · Cleared

Cleared

Molteno3 Glaucoma Implant

K152996510(k) TraditionalCleared Dec 17, 201565-day reviewClass II21 CFR 886.3920

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

Innovative Ophthalmic Products, Inc. (Iop) · KYF Implant, Eye Valve

Cleared on Dec 17, 2015 as substantially equivalent to K062252 (Iop, Inc., 2006) after a 65-day review. Its family tree reaches back 1 generation to 2006.

Decided
Dec 17, 2015
Review
65 days
Class
Class II
Product code
KYF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K062252 (2006). No later device cites it as a predicate yet.

K062252 · MOLTENO3 · Iop, Inc. · 2006 · recalled200620082010201220142016
K062252 · MOLTENO3 · Iop, Inc. · 2006 · recalled0
  1. Root · 1 generation backK062252 MOLTENO3Iop, Inc. · 2006 · Recalled
  2. This deviceK152996 Molteno3 Glaucoma ImplantInnovative Ophthalmic Products, Inc. (Iop) · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K062252MOLTENO3Iop, Inc.20061
0 (this device)K152996Molteno3 Glaucoma ImplantInnovative Ophthalmic Products, Inc. (Iop)2015—
FIG. 1 — Lineage of K152996, 2006–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KYF? 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 KYF device

  1. #1 K231051 Ahmed® Glaucoma Valve Model FP8score 6.2 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K062252MOLTENO3
Summary page 4
…Usual Name: Glaucoma Implant Classification Name: Aqueous Shunt (21 CFR 886.3920) Regulatory Class: II Product Code: KYF III.PREDICATE DEVICE Molteno3 G-Series Implant (K062252). This predicate has not been subject to a design-related recall. No reference devices were used in this submission. IV. DEVICE…
Iop, Inc.20061

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 a recall.

How does its category compare?

All KYF devices

KYF Implant, Eye Valve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · KYF

2in 2023

2015: 12016: 22017: 12019: 12022: 12023: 2
2007high 2 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KYF

Too few KYF 510(k)s in any year since 2007 to give a median.

Recalls per year · KYF

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · KYF

268in 2025

2007: 52008: 22009: 42010: 392011: 382012: 1162013: 1452014: 2882015: 2052016: 1982017: 2682018: 2582019: 5162020: 4372021: 4122022: 2992023: 3142024: 3122025: 268
2007high 516 (2019) · low 2 (2008)2025

MAUDE reports naming product code KYF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—05
20080—02
20090—04
20100—039
20110—038
20120—0116
20130—0145
20140—0288
20151—0205
20162—0198
20171—0268
20180—0258
20191—1516
20200—0437
20210—0412
20221—0299
20232—0314
20240—0312
20250—0268
20260—0—

What is it indicated for?

The Molteno3 S-Series glaucoma implant is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in KYF

The KYF category page

  • K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc. · 2023
  • K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc. · 2023
  • K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos Corporation · 2022
  • K182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc. · 2019
  • K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc. · 2017

https://510kreport.com/device/K152996 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152996: Molteno3 Glaucoma Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152996

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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