Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fukuda Denshi USA, Inc. — Predicate Candidate Screening
68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
255 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173226 | CardiMax Electrocardiograph | Fukuda Denshi USA, Inc. | 2018-04-16 | 195 | 0 |
| K150030 | Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor | Fukuda Denshi USA, Inc. | 2015-03-16 | 67 | 0 |
| K134046 | FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR | Fukuda Denshi USA, Inc. | 2015-02-12 | 408 | 1 |
| K112521 | FUKUDA DENSHI VASERA MODEL VS-1500 | Fukuda Denshi USA, Inc. | 2011-12-21 | 112 | 0 |
| K103134 | FUKUDA DENSHI | Fukuda Denshi USA, Inc. | 2011-03-11 | 137 | 0 |
| K083697 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR | Fukuda Denshi USA, Inc. | 2009-03-19 | 94 | 0 |
| K082656 | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMA | Fukuda Denshi USA, Inc. | 2008-09-30 | 18 | 0 |
| K081891 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR | Fukuda Denshi USA, Inc. | 2008-08-29 | 58 | 0 |
| K050363 | FUKUDA DENSHI MODEL UF-850XTD | Fukuda Denshi USA, Inc. | 2005-02-17 | 3 | 0 |
| K033711 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYST | Fukuda Denshi USA, Inc. | 2004-06-03 | 190 | 0 |
| K040246 | FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONIT | Fukuda Denshi USA, Inc. | 2004-05-26 | 113 | 0 |
| K033209 | FUKUDA DENSHI MODEL FF SONIC UF-750XT | Fukuda Denshi USA, Inc. | 2003-10-31 | 28 | 0 |
| K032290 | FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIEN | Fukuda Denshi USA, Inc. | 2003-10-10 | 78 | 0 |
| K020084 | FUKUDA DENSHI DYNASCOPE MODEL DS-5700 | Fukuda Denshi USA, Inc. | 2002-02-06 | 27 | 0 |
| K013273 | FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE | Fukuda Denshi USA, Inc. | 2001-12-20 | 80 | 0 |
| K000746 | FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX | Fukuda Denshi USA, Inc. | 2000-04-07 | 30 | 0 |
| K990401 | FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SC | Fukuda Denshi USA, Inc. | 1999-10-15 | 248 | 0 |
| K981066 | FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTR | Fukuda Denshi USA, Inc. | 1998-08-31 | 160 | 0 |
| K980728 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTE | Fukuda Denshi USA, Inc. | 1998-06-19 | 114 | 0 |
| K980979 | FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE | Fukuda Denshi USA, Inc. | 1998-06-12 | 87 | 0 |
| K981404 | FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 | Fukuda Denshi USA, Inc. | 1998-05-20 | 33 | 0 |
| K971440 | FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELE | Fukuda Denshi USA, Inc. | 1997-12-02 | 228 | 0 |
| K971131 | FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1997-10-03 | 190 | 0 |
| K970585 | FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITO | Fukuda Denshi USA, Inc. | 1997-09-09 | 207 | 0 |
| K964187 | FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1997-05-01 | 192 | 0 |
| K963057 | FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER | Fukuda Denshi USA, Inc. | 1997-03-21 | 227 | 0 |
| K955543 | ULTRASOUND SYSTEM MODEL UF-3500 | Fukuda Denshi USA, Inc. | 1997-02-11 | 434 | 0 |
| K955416 | CARDIMAX MODEL FX-2111 | Fukuda Denshi USA, Inc. | 1996-07-15 | 231 | 0 |
| K950044 | FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE | Fukuda Denshi USA, Inc. | 1995-09-15 | 253 | 0 |
| K944262 | ECG MONITOR | Fukuda Denshi USA, Inc. | 1995-05-12 | 255 | 0 |
| K945464 | FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE | Fukuda Denshi USA, Inc. | 1995-02-01 | 86 | 0 |
| K921454 | FUKUDA DENSHI MODEL HG-301 | Fukuda Denshi USA, Inc. | 1994-04-01 | 736 | 0 |
| K922208 | FUKUDA DENSHI MODEL UF-4500 | Fukuda Denshi USA, Inc. | 1993-08-30 | 475 | 0 |
| K922428 | FUKUDA DENSHI MODEL SPIROSIFT SP-5000 | Fukuda Denshi USA, Inc. | 1993-01-15 | 238 | 0 |
| K915879 | HL-300 RECEIVER MODULE | Fukuda Denshi USA, Inc. | 1992-01-27 | 28 | 0 |
| K913811 | FUKUDA DENSHI MODEL FCP-4101 | Fukuda Denshi USA, Inc. | 1991-12-09 | 105 | 0 |
| K904200 | SPIROSIFT 500A | Fukuda Denshi USA, Inc. | 1991-05-22 | 252 | 0 |
| K903514 | FUKUDA DENSHI MODEL LX-3100 | Fukuda Denshi USA, Inc. | 1991-01-30 | 180 | 0 |
| K903704 | FUKUDA DENSHI MODEL FCP-2201 MODIFICATION | Fukuda Denshi USA, Inc. | 1990-09-07 | 87 | 0 |
| K901817 | FUKUDA DENSHI MODEL FX-3101 | Fukuda Denshi USA, Inc. | 1990-08-23 | 122 | 0 |
| K901889 | FUKUDA DENSHI MODEL HJ-310 | Fukuda Denshi USA, Inc. | 1990-07-17 | 82 | 0 |
| K900391 | FUKUDA DENSHI MODEL SPIROSIFT 3000 | Fukuda Denshi USA, Inc. | 1990-04-10 | 74 | 0 |
| K897063 | FUKUDA DENSHI MODEL DS-3300 ETR | Fukuda Denshi USA, Inc. | 1990-02-01 | 43 | 0 |
| K897094 | MODIFIED SPIROSCAN 1000 | Fukuda Denshi USA, Inc. | 1990-01-12 | 23 | 0 |
| K894628 | MODEL DS-3300 DYNASCOPE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1990-01-08 | 168 | 0 |
| K893405 | MODEL DS-504 DYNASCOPE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1989-10-02 | 153 | 0 |
| K892796 | FUKUDA DENSHI MODEL FCP-2201 | Fukuda Denshi USA, Inc. | 1989-10-02 | 168 | 0 |
| K884992 | FUKUDA DENSHI MODEL FX-1201 | Fukuda Denshi USA, Inc. | 1989-01-12 | 42 | 0 |
| K875057 | FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1988-03-22 | 104 | 0 |
| K874768 | FUKUDA DENSHI MODEL FCP-231 | Fukuda Denshi USA, Inc. | 1987-12-18 | 29 | 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