Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FMP — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
30 daysmedian FDA review time
88 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150243 | Invictus Medical GelShield | Invictus Medical, Inc. | 2015-05-01 | 88 | 0 |
| K951325 | COMFEEL PLUS PRESSURE RELIEF DRESSING | Richard Hamer Assoc., Inc. | 1995-07-31 | 130 | 0 |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | Medsurg Industries, Inc. | 1994-03-28 | 180 | 0 |
| K820584 | DECUBICARE PADS & ACCESSORIES | Abco Dealers, Inc. | 1982-03-25 | 21 | 0 |
| K812344 | HEEL OR ELBOW PROTECTOR | Fred Sammons, Inc. | 1981-09-11 | 24 | 0 |
| K811184 | SPENCO DERMAL PADS | Spenco Medical Corp. | 1981-05-20 | 21 | 0 |
| K802829 | SCANLAN VASCU-STATT | Scanlan Intl., Inc. | 1981-01-15 | 66 | 0 |
| K802185 | ARTERIAL BLOOD SAMPLING KIT | Current Technologies, Inc. | 1980-10-10 | 30 | 0 |
| K801694 | FLOTATION PAD FOR OPERATING TABLE | Action Products, Inc. | 1980-08-27 | 35 | 0 |
| K801195 | DERMALEX OR NATRAWOOL SKIN PRESSURE PROT | Stock Wild & Co. | 1980-06-09 | 24 | 0 |
| K792297 | SPAN AIDS KIT | American Hospital Supply Corp. | 1979-12-20 | 34 | 0 |
| K791709 | HEEL/ELBOW PROTECTORS | Fibre Formations, Inc. | 1979-09-24 | 28 | 0 |
| K790995 | CONTEX | Foam Tek, Inc. | 1979-06-11 | 13 | 0 |
| K781246 | FOAM COMFORT RINGS | Fibre Formations, Inc. | 1978-08-10 | 20 | 0 |
| K780171 | ELBOW PROTECTOR | Stat Medical Corp. | 1978-02-06 | 4 | 0 |
| K772419 | HEEL OR ELBOW PROTECTOR | Fred Sammons, Inc. | 1978-01-26 | 30 | 0 |
| K772060 | PROTECT IV GARD | Omnicon Medical Corp. | 1977-12-20 | 50 | 0 |
| K771913 | HEEL/ELBOW PROTECTOR | Alba-Waldensian, Inc. | 1977-11-15 | 35 | 0 |
| K771633 | HEEL PROTECTOR | Medical Restraints, Inc. | 1977-09-12 | 17 | 0 |
| K771519 | SPECIALIST ARM & LEG PROTECTOR | Johnson & Johnson Professionals, Inc. | 1977-08-26 | 18 | 0 |
| K770635 | PROTECTOR, HEEL & ELBOW | Tecnol New Jersey Wound Care, Inc. | 1977-05-23 | 49 | 0 |
| K761268 | SKIN PRESSURE PROTECTORS | Mark One Healthcare Products | 1977-02-16 | 62 | 0 |
| K760870 | HEEL/ELBOW FLOTATION CUSHION | Medpro, Inc. | 1976-11-01 | 14 | 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