Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fred Sammons, Inc. — Predicate Candidate Screening
278 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
17 daysmedian FDA review time
47 days90th percentile
278clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K880644 | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | Fred Sammons, Inc. | 1988-05-06 | 80 | 0 |
| K880647 | ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) | Fred Sammons, Inc. | 1988-04-01 | 45 | 0 |
| K831549 | ARM SLINGS | Fred Sammons, Inc. | 1983-06-30 | 49 | 0 |
| K831548 | SPLINTS | Fred Sammons, Inc. | 1983-06-27 | 46 | 0 |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Fred Sammons, Inc. | 1983-06-24 | 43 | 0 |
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Fred Sammons, Inc. | 1983-06-24 | 43 | 0 |
| K831550 | FINGER BONIOMETER BK7506 | Fred Sammons, Inc. | 1983-06-24 | 43 | 0 |
| K831542 | ADJUSTABLE POLYCENTRIC ELBOW HINGE | Fred Sammons, Inc. | 1983-06-24 | 43 | 0 |
| K831553 | LEG DRAINAGE BAG STRAP BK6011 | Fred Sammons, Inc. | 1983-06-16 | 35 | 0 |
| K831545 | REACHER & DOOR OPENER | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K831552 | SORBOTHANE VISCO INNER SOLE PAD | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K831546 | ADAPTIVE PENS & LAP DESK | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K831540 | COMPRESSOGRIP ELASTIC STUMP SHRINKER# | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K831538 | DELUXE ADJUST-ANGLE BOARD-BK4066 | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K831539 | ECONOMY PLASTIC SOCK-BK2084-AID | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K831551 | COMPRESSOGRIP TUBULAR ELASTIC BANDAGE | Fred Sammons, Inc. | 1983-06-07 | 26 | 0 |
| K831541 | TUB TRANSFER BENCH BK6481 | Fred Sammons, Inc. | 1983-06-02 | 21 | 0 |
| K823631 | NON-SLIP VINYL BATH MAT | Fred Sammons, Inc. | 1983-02-03 | 59 | 0 |
| K823653 | THINNING SOLUTION SALVENT BASED COAT-MAT | Fred Sammons, Inc. | 1983-02-03 | 59 | 0 |
| K823655 | BOOK ON MGMT. OF THE BURN PATIENT | Fred Sammons, Inc. | 1983-02-03 | 59 | 0 |
| K823598 | LARGE TERRYCLOTH BIB | Fred Sammons, Inc. | 1983-02-03 | 59 | 0 |
| K823652 | PRIMARY SOLUTION SALVENT BASED COAT- MET | Fred Sammons, Inc. | 1983-02-03 | 59 | 0 |
| K823651 | SCISSORS | Fred Sammons, Inc. | 1983-02-03 | 59 | 0 |
| K823643 | INFLATABLE PILLOW | Fred Sammons, Inc. | 1983-02-03 | 59 | 0 |
| K823654 | SLIP-ON SANDALS FOR MEASURING SHORTNESS | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823657 | CARD HOLDER FOR QUADS | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823647 | FINGER EXTENSION SPLINT | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823641 | BATHING CHAIR FOR CHILD | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823638 | ARM THROUGH FOR WHEELCHAIR BK 6454-01 & | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823648 | SURGICAL TUBING | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823646 | FRICTION FEEDER | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823649 | THERMOELASTOMER HOT/COLD COMPRESS BK7186 | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823644 | FINGER FLEXION SPLINT | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823645 | VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823656 | SOFT CATCHER'S MITT | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823650 | THERMOELASTOMER HOT/COLD COMPRESS-7187- | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823637 | ARM THROUGH FOR WHEELCHAIR BK-6458-01 | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823640 | BATH TUB SAFETY BAR | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823639 | BOARD TO TRANSFER PARALYZED PATIENT FROM | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823626 | DISPOSABLE TOOTH BRUSH | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823625 | MOUTH STICK KIT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823608 | PICTURES & WORD IDENTIFICATION CVA PAT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823624 | HOLDER FOR MOUTH STICK | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823629 | FORMED STEEL DEVICE KEEP LEGS SEPARATED | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823622 | INSULATED THERMOELASTOMER MITT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823612 | ADJ. WOODEN BOARD FOR WRITING | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823636 | ARM THROUGH FOR WHEELCHAIR BK-6459-01 & | Fred Sammons, Inc. | 1982-12-28 | 22 | 0 |
| K823604 | ROD W/HOOK TO PULL CLOTHES ON | Fred Sammons, Inc. | 1982-12-28 | 22 | 0 |
| K823634 | CHAIR OR BED LEG EXTENDERS | Fred Sammons, Inc. | 1982-12-28 | 22 | 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