Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LCJ — Predicate Candidate Screening
55 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
344 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | 2026-01-16 | 28 | 0 |
| K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC | 2025-04-24 | 211 | 0 |
| K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2025-01-12 | 30 | 0 |
| K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2024-08-02 | 32 | 3 |
| K211676 | Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC | 2023-10-13 | 864 | 0 |
| K214124 | AlloX2 Pro Tissue Expanders | Sientra, Inc. | 2023-06-08 | 525 | 0 |
| K221127 | Sientra, inc. Portfinder | Sientra, Inc. | 2023-05-10 | 387 | 0 |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | 2018-12-21 | 266 | 0 |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC | 2018-09-25 | 28 | 0 |
| K182054 | Natrelle 133S Tissue Expander | Allergan | 2018-08-29 | 29 | 0 |
| K161483 | Unger Quad Injector | Stradis Healthcare | 2016-10-31 | 153 | 0 |
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | 2016-05-23 | 27 | 2 |
| K152496 | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | 2016-02-19 | 171 | 0 |
| K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015-08-20 | 269 | 1 |
| K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | 2015-04-24 | 30 | 2 |
| K142998 | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | 2014-12-19 | 63 | 0 |
| K140383 | ALLOX2 TISSUE EXPANDERS | Specialty Surgical Products, Inc. | 2014-10-28 | 256 | 0 |
| K131692 | BLOSSOM SALINE DELIVERY ASSIST DEVICE | Marz Medical, Inc. | 2014-07-10 | 395 | 0 |
| K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH S | Mentor Corp. | 2013-04-11 | 17 | 4 |
| K112534 | LIFECELL TISSUE EXPANDER | Lifecell Corp. | 2012-08-10 | 344 | 0 |
| K102806 | NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS | Allergan Medical | 2011-01-05 | 99 | 2 |
| K070303 | SILICONE TISSUE EXPANDER | Specialty Surgical Products | 2007-06-22 | 142 | 0 |
| K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER | Mentor Corp. | 2001-12-03 | 201 | 0 |
| K983385 | HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS | Hutchison Intl., Inc. | 1999-03-15 | 171 | 0 |
| K983792 | SEARE BIOMEDICAL SILICONE TISSUE EXPANDER | Seare Biomedical Corp. | 1998-12-11 | 45 | 0 |
| K981852 | SILIMED TISSUE EXPANDER | Silimed, LLC | 1998-08-05 | 71 | 0 |
| K982067 | MAGNETIC PORT SILICONE TISSUE EXPANDER | Specialty Surgical Products, Inc. | 1998-07-13 | 31 | 0 |
| K974209 | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER | Specialty Surgical Products, Inc. | 1998-02-06 | 88 | 0 |
| K963066 | MENTOR INJECTION PORT DETECTOR (IPD) | Mentor Corp. | 1996-09-27 | 51 | 0 |
| K905484 | ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT | Mentor Corp. | 1991-02-11 | 67 | 0 |
| K903448 | SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER | Medical Engineering Corp. | 1991-01-14 | 167 | 0 |
| K894475 | MENTOR TISSUE EXPANDERS W/TDMAC COATING | Mentor Corp. | 1990-11-26 | 496 | 0 |
| K894495 | SURGITEK(R) EXTERNAL FILL PORT | Surgitek | 1990-01-17 | 182 | 0 |
| K884746 | SURGITEK FLAT T-SPAN | Medical Engineering Corp. | 1989-08-10 | 269 | 0 |
| K884250 | RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) | Mentor Corp. | 1989-06-12 | 244 | 0 |
| K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER | Cox-Uphuff Intl. | 1987-05-22 | 149 | 1 |
| K870754 | MCGHAN TISSUE EXPANDER FILL SYSTEM | Mcghan Medical Corp. | 1987-03-31 | 33 | 0 |
| K870154 | POREX(TM) TISSUE EXPANDER | Porex Medical | 1987-02-24 | 42 | 0 |
| K865033 | BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER | Cox-Uphuff Intl. | 1987-01-12 | 20 | 0 |
| K864184 | MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN | Mcghan Medical Corp. | 1986-12-24 | 58 | 0 |
| K864185 | MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN | Mcghan Medical Corp. | 1986-12-24 | 58 | 0 |
| K862203 | MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER | Mcghan Medical Corp. | 1986-07-23 | 43 | 4 |
| K862049 | MENTOR FLAT-SPAN | Mentor Corp. | 1986-06-10 | 12 | 0 |
| K854794 | MCGHAN INTEGRAL VALVE TISSUE EXPANDER | Mcghan Medical Corp. | 1985-12-24 | 22 | 0 |
| K853014 | MCGHAN TISSUE EXPANDER FILL KIT | Mcghan Medical Corp. | 1985-09-18 | 63 | 1 |
| K845036 | TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 | Progress Mankind Technology | 1985-06-26 | 181 | 0 |
| K844813 | MENTOR EXPANDER MAMMARY PROSTHESIS | Mentor Corp. | 1985-05-10 | 150 | 0 |
| K843678 | CREAT BRAND SKIN EXPANDER | Aesthetech Corp. | 1984-11-06 | 49 | 0 |
| K843704 | MCGHAN TISSUE EXPANDER | Mcghan Medical Corp. | 1984-10-31 | 40 | 0 |
| K842883 | RADOVAN TISSUE EXPANDER | Mentor Corp. | 1984-08-17 | 25 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda