510(k) · Cleared
ClearedPre-Formed Silicone Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Medical Devices, Inc. · MIB Elastomer, Silicone Block
Cleared on Feb 3, 2023 as substantially equivalent to K042380 (National Medical Devices, Inc., 2004) and 3 other predicates after a 127-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Feb 3, 2023
- Review
- 127 days
- Class
- Class II
- Product code
- MIB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K021839 (2002). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK021839 Aart Gluteal ImplantAesthetic and Reconstructive Technologies, Inc. · 2002 · Recalled
- 3 generations backK162624 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2017
- 2 generations backK181387 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2019
- 1 generation backK220760 Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc. · 2022
- This deviceK223051 Pre-Formed Silicone BlockInternational Medical Devices, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K021839 | Aart Gluteal Implant | Aesthetic and Reconstructive Technologies, Inc. | 2002 | 1 |
| −3 | K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017 | — |
| −2 | K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019 | — |
| −1 | K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2022 | — |
| 0 (this device) | K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K042380 | Silicone BlockSummary page 4…is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K042380 Silicone Block / National Medical Devices, Inc.* Pre-Formed Penile Sil… | 2004 |
| * | K220760 | Pre-Formed Penile Silicone BlockSummary page 4…Silicone Block / National Medical Devices, Inc.* Pre-Formed Penile Silicone Block / International Medical K220760 Devices, Inc. K162624 / Pre-Formed Penile Silicone Block / International Medical… | 2022 |
| * | K162624 | Pre-Formed Penile Silicone BlockSummary page 4….* Pre-Formed Penile Silicone Block / International Medical K220760 Devices, Inc. K162624 / Pre-Formed Penile Silicone Block / International Medical K181387 Devices, Inc. * National Medical Devi… | 2017 |
| * | K181387 | Pre-Formed Penile Silicone BlockSummary page 4…/ International Medical K220760 Devices, Inc. K162624 / Pre-Formed Penile Silicone Block / International Medical K181387 Devices, Inc. * National Medical Devices, Inc. is now International Medical Devices, Inc. 510(k) Summary… | 2019 |
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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K042380.
How does its category compare?
All MIB devicesMIB Elastomer, Silicone Block: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MIB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MIB
102in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MIB
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MIB
18in 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 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 to aid in the reconstruction process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223051: Pre-Formed 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/K223051
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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