Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KGX — Predicate Candidate Screening
187 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
254 days90th percentile
187clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001240 | SERAGARD INJECTION PATCH | Platinum Services, Inc. | 2000-06-21 | 64 | 0 |
| K983368 | CARE BAND ANTIBACTERIAL BANDAGES | Aso Corp. | 1999-02-17 | 146 | 0 |
| K972914 | SYVEK PATCH | Marine Polymer Technologies, Inc. | 1997-12-22 | 137 | 0 |
| K943314 | ADHESIVE BANDAGES WITH OTC DRUG | Johnson & Johnson Consumer Products, Inc. | 1996-01-17 | 555 | 0 |
| K952606 | TARGETT PATCH | Cutting Edge Technologies, Inc. | 1995-12-21 | 198 | 0 |
| K954007 | PARALLEL | Johnson & Johnson Consumer Products, Inc. | 1995-11-22 | 89 | 0 |
| K944587 | DERMIVIEW HYPOALLERGENIC CLEAR TAPE | Johnson & Johnson Medical, Inc. | 1995-10-30 | 406 | 0 |
| K944588 | STERILE PLASTIC DRESSING | Smith & Nephew, Inc. | 1994-11-07 | 49 | 0 |
| K941788 | BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP | Johnson & Johnson Consumer Products, Inc. | 1994-10-03 | 175 | 0 |
| K940536 | BAND-AID(TM) BRAND ADHESIVE BANDAGE | Johnson & Johnson Consumer Products, Inc. | 1994-10-03 | 238 | 0 |
| K940798 | SHIPPERT PRESSURE BANDAGE | Denver Splint Co. | 1994-09-28 | 218 | 0 |
| K941389 | EMPI TAPE PATCHES | Empi | 1994-08-23 | 154 | 0 |
| K942383 | DERMIVIEW CLEAR TAPE | Johnson & Johnson International | 1994-08-22 | 95 | 0 |
| K940378 | COVERLET ADHESIVE DRESSING | Beiersdorf, Inc. | 1994-07-29 | 184 | 0 |
| K941499 | KIT PAK DRESSING CHANGE TRAY | Kit Pak, Inc. | 1994-07-20 | 113 | 0 |
| K941943 | SURGICAL ADHESIVE TAPE | Raleigh Lions Clinic For the Blind, Inc. | 1994-06-30 | 70 | 0 |
| K941379 | ACE SPORTS TAPE | Becton Dickinson Consumer Products | 1994-06-13 | 83 | 0 |
| K935948 | CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM | Convatec, A Division of E.R. Squibb & Sons | 1994-03-01 | 78 | 0 |
| K932457 | SPYROGEL WOUND DRESSING | Polymint Industrial Co. , Ltd. | 1994-02-09 | 264 | 0 |
| K935725 | EPISEAL ADHESIVE WOUND CLOSURE STRIPS | Deroyal Industries, Inc. | 1994-02-04 | 65 | 0 |
| K930457 | MEDIMAC BANDAGE | Enquay Pharmaceutical | 1994-01-25 | 362 | 0 |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | 3M Health Care, Ltd. | 1993-12-27 | 222 | 0 |
| K932743 | MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION | Scott Health Care | 1993-09-10 | 94 | 0 |
| K931886 | TISSUE ISOLATION AND RETRIEVAL BAG | Advanced Surgical, Inc. | 1993-09-07 | 145 | 0 |
| K924192 | I.V. START KIT (AHC-50-54954 | American Healthcare Corp. | 1993-08-27 | 372 | 0 |
| K922441 | SURESEAL BANDAGE | Gainor Medical Europe, Ltd. | 1993-08-10 | 445 | 0 |
| K932602 | ADHESIVE BANDAGES | Aso Corp. | 1993-08-09 | 73 | 0 |
| K924794 | TRANSPARENT ADHESIVE DRESSING | Medical Concepts Development, Inc. | 1993-07-08 | 288 | 0 |
| K923319 | SHAWNEE PRODUCT KIT IV | Absentee Shawnee Bandage Group | 1993-06-17 | 345 | 0 |
| K923235 | BIOCLUSIVE MVP TRANSPARENT DRESSING | Johnson & Johnson Medical, Inc. | 1993-05-12 | 315 | 0 |
| K925384 | ISOPORE(TM) TAPE, MODIFICATION | Lectec Corp. | 1993-04-21 | 177 | 0 |
| K926264 | MEDICOTEST SKIN FIX | Medicotest, Inc. | 1993-04-20 | 123 | 0 |
| K923662 | INGROWN TOENAIL PAD | Many Bee Co. | 1993-04-20 | 272 | 0 |
| K921761 | SHAWNEE PRODUCTS KIT II | Absentee Shawnee Bandage Group | 1993-03-18 | 338 | 0 |
| K923358 | LC STRIP | Genetic Laboratories Wound Care, Inc. | 1993-01-13 | 189 | 0 |
| K922228 | 2ND SKIN STERILE ADHESIVE STRIP | Spenco Medical Corp. | 1992-12-11 | 213 | 0 |
| K923400 | DERMCO A-I | Dermaco, Inc. | 1992-10-06 | 88 | 0 |
| K922897 | STRAPPAL | Smith & Nephew United, Inc. | 1992-09-15 | 91 | 0 |
| K922959 | ISOPORE TAPE | Lectec Corp. | 1992-09-11 | 85 | 0 |
| K923404 | LUEKOFLEX SURGICAL TAPE | Beiersdorf, Inc. | 1992-09-09 | 61 | 0 |
| K923300 | DEROYAL EYE DRESSING | Deroyal Industries, Inc. | 1992-09-01 | 57 | 0 |
| K920675 | DUODERM SUSTAINED COMPRESSION BANDAGE | Convatec, A Division of E.R. Squibb & Sons | 1992-08-18 | 186 | 0 |
| K921759 | ACRYLASTIC | Beiersdorf, Inc. | 1992-08-10 | 118 | 0 |
| K921760 | TRICOPLAST | Beiersdorf, Inc. | 1992-08-10 | 118 | 0 |
| K914733 | TTL MEDICATED DRESSING | Medimix Products, Inc. | 1992-07-01 | 254 | 0 |
| K915446 | STRETCH WRAP | Sun Glitz Corp. | 1992-05-06 | 153 | 0 |
| K915358 | PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH | Medtronic Vascular | 1992-04-28 | 153 | 0 |
| K920182 | MARION WINDOW | Tnt Moberg Intl. , Ltd. | 1992-03-26 | 71 | 0 |
| K914596 | SURGICAL CLOTH TAPE (HEALRITE) | Industrias Tuk, S.A. DE C.V. | 1992-03-19 | 155 | 0 |
| K915057 | CANN-HOLD | O.R. Concepts, Inc. | 1992-03-19 | 132 | 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