Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Molnlycke Health Care Us, LLC · Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
116 daysmedian FDA review time
255 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232508 | Barrier EasyWarm Active Self-Warming Blanket | Molnlycke Health Care Us, LLC | 2023-09-15 | 28 | 0 |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System | Molnlycke Health Care Us, LLC | 2021-07-01 | 227 | 0 |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel | Molnlycke Health Care Us, LLC | 2020-11-22 | 117 | 0 |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, | Molnlycke Health Care Us, LLC | 2020-04-10 | 109 | 0 |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatit | Molnlycke Health Care Us, LLC | 2020-03-13 | 245 | 0 |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Tou | Molnlycke Health Care Us, LLC | 2019-05-24 | 128 | 0 |
| K161939 | Avance Abdominal Dressing Kit | Molnlycke Health Care Us, LLC | 2016-11-17 | 126 | 0 |
| K161935 | Avance Foam Dressing Kit - XL | Molnlycke Health Care Us, LLC | 2016-11-04 | 113 | 0 |
| K161948 | Avance Gauze Dressing Kits | Molnlycke Health Care Us, LLC | 2016-11-03 | 111 | 0 |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | Molnlycke Health Care Us, LLC | 2016-10-19 | 111 | 0 |
| K160379 | Exufiber Ag+ | Molnlycke Health Care Us, LLC | 2016-08-25 | 197 | 0 |
| K152741 | Mepiseal Soft Silicone Sealant | Molnlycke Health Care Us, LLC | 2016-01-22 | 121 | 0 |
| K151872 | Avance Y-Connector S | Molnlycke Health Care Us, LLC | 2015-11-02 | 116 | 0 |
| K150146 | Biogel PI Micro Indicator Underglove | Molnlycke Health Care Us, LLC | 2015-08-31 | 221 | 0 |
| K141847 | AVANCE FOAM DRESSING KITS | Molnlycke Health Care Us, LLC | 2015-03-26 | 260 | 0 |
| K140477 | BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL G | Molnlycke Health Care Us, LLC | 2015-03-23 | 390 | 0 |
| K141719 | BIOGEL PL MICRO SURGICAL GLOVE | Molnlycke Health Care Us, LLC | 2014-09-04 | 71 | 0 |
| K132048 | BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET | Molnlycke Health Care Us, LLC | 2013-11-06 | 127 | 0 |
| K111413 | BIOGEL (R) INDICATOR (R) UNDERGLOVE | Molnlycke Health Care Us, LLC | 2012-01-30 | 255 | 0 |
| K112257 | BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE | Molnlycke Health Care Us, LLC | 2011-09-20 | 46 | 0 |
| K112089 | BIOGEL ORTHOPOR BROWN SURGICAL GLOVE | Molnlycke Health Care Us, LLC | 2011-08-24 | 34 | 0 |
| K081180 | SKINSENSE POLYISOPRENE UNDERGLOVE | Molnlycke Health Care Us, LLC | 2008-08-26 | 123 | 0 |
| K071465 | BIOGEL ORTHOPAEDIC SURGICAL GLOVE WITH NON-PRYOGENIC STATEME | Molnlycke Health Care Us, LLC | 2007-09-11 | 105 | 0 |
| K071700 | BIOGEL SENSOR SURGEON'S GLOVE WITH NON-PYROGENIC STATEMENT | Molnlycke Health Care Us, LLC | 2007-09-11 | 82 | 0 |
| K071414 | BIOGEL ECLIPSE, LATEX, POWDER FREE, INDICATOR UNDERGLOVE WIT | Molnlycke Health Care Us, LLC | 2007-09-10 | 112 | 0 |
| K071565 | BIOGEL INDICATOR UNDERGLOVE WITH NON-PYROGENIC STATEMENT | Molnlycke Health Care Us, LLC | 2007-09-10 | 95 | 0 |
| K062847 | BIOGEL ECLIPSE INDICATOR UNDERGLOVE | Molnlycke Health Care Us, LLC | 2006-12-20 | 77 | 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