Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FRW — Predicate Candidate Screening
48 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
274 days90th percentile
48clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955357 | OLYMPIC SMART SCALE MODEL 50/50RA | Olympic Medical Corp. | 1996-01-30 | 99 | 0 |
| K954846 | OLYMPIC SMART SCALE | Olympic Medical Corp. | 1995-12-14 | 52 | 0 |
| K955177 | OLYMPIC SMART SCALE | Olympic Medical Corp. | 1995-12-14 | 31 | 0 |
| K952649 | WARM-SCALE | Olympic Medical Corp. | 1995-08-15 | 67 | 0 |
| K943587 | ADVANCED IN-BED WEIGH SYSTEM | Future Systems, Inc. | 1994-09-22 | 62 | 0 |
| K932572 | DIGITAL BABY SCALE MODEL BLB-12 | Tanita Corp. of America | 1993-11-16 | 173 | 0 |
| K926174 | MODEL 9100 H.R. INFANT SCALE | Acme Medical Scale Co. | 1993-10-25 | 321 | 0 |
| K926446 | EZ PUMP | Alphamed, Inc. | 1993-09-27 | 278 | 0 |
| K926059 | 3M MODEL 200RT RATE TAPER INFUSION PUMP | 3M Health Care, Ltd. | 1993-08-16 | 258 | 0 |
| K926058 | 3M MODEL 280RT RATE TAPER INFUSION PUMP | 3M Health Care, Ltd. | 1993-08-16 | 258 | 0 |
| K930626 | SANITAS PATIENT SCALE | Dutton-Lainson Co. | 1993-08-06 | 179 | 0 |
| K920063 | DISETRONIC DOLOMAT PUMP | Disetronic Medical Systems | 1993-08-03 | 574 | 0 |
| K924847 | DETECTO MODEL 6700 SERIES | Cardinal Scale Mfg. Co. | 1993-05-24 | 238 | 0 |
| K922119 | MODEL 5002 LIFT WEIGH-SCALE | Acme Medical Scale Co. | 1993-02-03 | 274 | 0 |
| K920812 | FAIRBANKS BABY SCALE | Fairbanks Scales, Inc. | 1992-05-13 | 82 | 0 |
| K920074 | ARJO CENTURY SCALES WITH REMOTE | Arjo-Century, Inc. | 1992-04-06 | 90 | 0 |
| K912662 | SCALE-TRONIX PLATFORM SCALE | Scale-Tronix, Inc. | 1992-03-27 | 283 | 0 |
| K910582 | U.S. MEDICAL PS-2000 PEDIATRIC SCALE | U.S. Medical Corp. | 1991-03-21 | 38 | 0 |
| K910581 | U.S. MEDICAL PS-1000 PEDIATRIC SCALE | U.S. Medical Corp. | 1991-03-21 | 38 | 0 |
| K910583 | U.S. MEDICAL PS-3000 NEONATAL SCALE | U.S. Medical Corp. | 1991-03-21 | 38 | 0 |
| K905122 | SENTRY SCALE | Apollo Enterprise, Ltd. Co. | 1991-03-15 | 121 | 0 |
| K905061 | APOLLO MOBILE SCALE | Apollo Enterprise, Ltd. Co. | 1991-02-12 | 95 | 0 |
| K904138 | SMART SCALE X-RAY PLATFORM | Olympic Medical Corp. | 1990-11-19 | 74 | 0 |
| K904286 | SCALE-TRONIX INCUBATOR SCALE MODEL:4050/MODIFIED | Scale-Tronix, Inc. | 1990-10-01 | 33 | 0 |
| K902260 | SCALE-TRONIX INCUBATOR SCALE MODEL:4050 | Scale-Tronix, Inc. | 1990-08-14 | 85 | 0 |
| K902545 | VAAKA BABY SCALE | Ferguson Medical | 1990-07-26 | 48 | 0 |
| K901522 | OLYMPIC SMART SCALE PEDIATRICS MODEL 50 | Olympic Medical Corp. | 1990-06-22 | 81 | 0 |
| K872524 | SAFEWEIGH MAGIC SCALE | Health Care Innovations, Inc. | 1987-10-09 | 106 | 0 |
| K871771 | COMFORTWEIGH | Curlington Industrial Electronics, Inc. | 1987-06-24 | 49 | 0 |
| K871104 | OLYMPIC SMART SCALE | Olympic Medical Corp. | 1987-05-22 | 64 | 0 |
| K870888 | WARM WEIGH MODEL N-10 INFANT SCALE | Air-Shields, Inc. | 1987-03-17 | 12 | 0 |
| K864327 | MODEL 304-S EXTERNAL MICRO-VOLUME INFUSION PUMP | Medtronic Minimed | 1987-02-06 | 94 | 0 |
| K864953 | WEIGHMOBILE, IN BED PATIENT WEIGHING SCALE | Dittmar and Penn Corp. | 1987-01-21 | 34 | 0 |
| K862477 | HOYER DIGITAL ELECTRONIC SCALE | Ted Hoyer & Co., Inc. | 1986-09-03 | 65 | 0 |
| K853475 | GRAM-MA NEONATAL SC | Kentec Medical, Inc. | 1985-09-05 | 16 | 0 |
| K852278 | ACME(BRAND) LOW-PROFILE WHEELCHAIR SCALE, 17400 | Acme Medical Scale Co. | 1985-06-07 | 9 | 0 |
| K852035 | HEALTH-O-METER PHYSICIANS, DIGITAL ELEC SCALES | Continental Scale Corp. | 1985-05-29 | 20 | 0 |
| K851014 | ACME LOW-PROFILE CHAIR SCAL 7300 | Acme Medical Scale Co. | 1985-03-27 | 15 | 0 |
| K841534 | ACME DIGITAL INFANT SCALE-30 | Acme Medical Scale Co. | 1984-05-31 | 45 | 0 |
| K833754 | HAMILTON PEDIATRICS SCALE | Befour, Inc. | 1984-01-11 | 77 | 0 |
| K830317 | INFUSION PUMP ACCESS. #60-01-5 | Windsor Medical, Inc. | 1983-03-31 | 59 | 0 |
| K830171 | DIGITAL BEDSIDE SCALE #5000 | Acme Medical Scale Co. | 1983-02-18 | 31 | 0 |
| K822135 | SECA DIGITAL BABY SCALE 727 | Seca Corp. | 1982-07-30 | 10 | 0 |
| K822043 | SECA CHAIR SCALE-721 | Seca Corp. | 1982-07-28 | 16 | 0 |
| K822042 | SECA LIGHT WEIGHT BABY SCALE 744 | Seca Corp. | 1982-07-28 | 16 | 0 |
| K791566 | MODEL AS* 6C INFUSION PUMP | Baxter Healthcare Corp | 1979-11-13 | 95 | 0 |
| K781832 | SCALE, ACME DIGITAL BEDSIDE | Acme Medical Scale Co. | 1978-12-07 | 38 | 0 |
| K760545 | WEIGHING STATION, MOBILE PATIENT | Gaymar Industries, Inc. | 1976-11-12 | 74 | 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