510(k) · Cleared

Cleared

Pre-Formed Penile Silicone Block

K162624510(k) TraditionalCleared Feb 1, 2017134-day reviewClass II21 CFR 874.3620

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

International Medical Devices, Inc. · MIB Elastomer, Silicone Block

Cleared on Feb 1, 2017 as substantially equivalent to K042380 (National Medical Devices, Inc., 2004) and 3 other predicates after a 134-day review. Its family tree reaches back 1 generation to 2002. 4 later devices descend from it.

Decided: Feb 1, 2017
Review: 134 days
Class: Class II
Product code: MIB
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K021839 (2002). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK021839 Aart Gluteal ImplantAesthetic and Reconstructive Technologies, Inc. · 2002 · Recalled
This deviceK162624 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2017
Descendant · cites it directly · 3 of its ownK181387 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019
Descendant · 2 generations on · 1 of its ownK220760 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022
Descendant · cites it directly · 0 of its ownK223051 Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023
Descendant · 2 generations on · 0 of its ownK200073 AugMENTA Penile ImplantAugmenta, LLC · 2022

Most influential descendants

Showing 4 of 4 · See all

K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019 · cites it directly3descendants
K220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022 · 2 generations on1descendant
K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023 · cites it directly0descendants
K200073AugMENTA Penile ImplantAugmenta, LLC · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K021839	Aart Gluteal Implant	Aesthetic and Reconstructive Technologies, Inc.	2002	1
0 (this device)	K162624	Pre-Formed Penile Silicone Block	International Medical Devices, Inc.	2017	—
+1	K181387	Pre-Formed Penile Silicone Block	International Medical Devices, Inc.	2019	—
+2	K220760	Pre-Formed Penile Silicone Block	International Medical Devices, Inc.	2022	—
+1	K223051	Pre-Formed Silicone Block	International Medical Devices, Inc.	2023	—
+2	K200073	AugMENTA Penile Implant	Augmenta, LLC	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2022	2	0
2023	1	0

FIG. 1 — Lineage of K162624, 2002–2023Source: 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 MIB? 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 MIB device

#1 K241150 MISTI Silicone Implantscore 8.0 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) 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	Applicant	Decided	Recalls
*	K042380	Silicone Block Summary page 5 …acturer Primary Number Predicate K042380 Silicone Block / National Medical Devices, Inc.* 9 K040042 Medisil Silicone Sheeting /…	National Medical Devices, Inc.	2004	—
*	K040042	Medisil Silicone Sheeting Summary page 5 …Predicate K042380 Silicone Block / National Medical Devices, Inc.* 9 K040042 Medisil Silicone Sheeting / Medisil Corporation K022511 AART Calf Implant / Aesthetic and Reconstructive Technologies, In…	Medisil Corporation	2004	—
*	K022511	Aart Calf Implant Summary page 5 …K042380 Silicone Block / National Medical Devices, Inc.* 9 K040042 Medisil Silicone Sheeting / Medisil Corporation K022511 AART Calf Implant / Aesthetic and Reconstructive Technologies, Inc. K021839 AART Gluteal Implant / Aesthetic and Reconstr…	Aesthetic and Reconstructive Technologies, Inc.	2002	1
*	K021839	Aart Gluteal Implant Summary page 5 …9 K040042 Medisil Silicone Sheeting / Medisil Corporation K022511 AART Calf Implant / Aesthetic and Reconstructive Technologies, Inc. K021839 AART Gluteal Implant / Aesthetic and Reconstructive Technologies, Inc. * National Medical Devices, Inc. is now Internationa…	Aesthetic and Reconstructive Technologies, Inc.	2002	1

Also cleared against K042380: 1 other device →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K181387	Pre-Formed Penile Silicone Block	International Medical Devices, Inc.	2019	3
K223051	Pre-Formed Silicone Block	International Medical Devices, Inc.	2023	0

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?

2 of the 4 ancestors have a recall of any class.
Of its descendants, K181387 (International Medical Devices, Inc., 2019) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K042380.

How does its category compare?

All MIB devices

MIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · MIB

1in 2024

2007high 3 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MIB

102in 2022

2007high 102 (2022)2026

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

Recalls per year · MIB

3in 2025

2007high 3 (2025) · low 0 (2007)2026

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

Adverse event reports per year · MIB

18in 2025

2007high 74 (2023) · low 0 (2007)2025

MAUDE reports naming product code MIB, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	2
2011	0	—	0	1
2012	0	—	0	2
2013	0	—	0	0
2014	0	—	0	1
2015	0	—	0	2
2016	0	—	0	1
2017	1	—	0	1
2018	1	—	0	10
2019	1	—	0	3
2020	1	—	0	1
2021	0	—	0	5
2022	3	102	0	19
2023	1	—	0	74
2024	1	—	0	32
2025	0	—	3	18
2026	0	—	0	—

What is it indicated for?

The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon’s discretion to create a custom implant.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162624 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162624: Pre-Formed Penile Silicone Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162624

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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