Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1984 — Predicate Candidate Screening
4,397 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
52 daysmedian FDA review time
154 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833644 | FILTER PURGE LINE EC-FPL SERIES | Gish Biomedical, Inc. | 1984-12-29 | 439 | 0 |
| K842964 | PHOTIC STIMULATOR TM-3030-70 | Tracor Northern, Inc. | 1984-12-28 | 154 | 0 |
| K844912 | SERVO VENTILATOR 900D SIEMENS-ELEMA AB | Siemens Elema AB | 1984-12-28 | 10 | 0 |
| K844457 | SECURIPIN | Hughes Int'L, Inc. | 1984-12-27 | 41 | 0 |
| K840417 | EBNA ACIF KIT | Litton Bionetics | 1984-12-27 | 331 | 0 |
| K844035 | MENSTRUAL PADS | American Disposable Products Corp. | 1984-12-27 | 72 | 0 |
| K842373 | VENOUS RESERVOIR-BMR-1500-HARD SHELL | American Bentley | 1984-12-27 | 195 | 0 |
| K844852 | THE GENERIC OXYGEN CONCENTRATOR | Proto-Med, Inc. | 1984-12-27 | 14 | 0 |
| K844350 | NEWPORT VENTILATOR MODEL E-100 | Newport Medical Instruments, Inc. | 1984-12-27 | 48 | 0 |
| K843841 | ERGO-OXYSCREEN | Erich Jaeger, Inc. | 1984-12-27 | 87 | 0 |
| K844137 | STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN | Shiley, Inc. | 1984-12-27 | 65 | 0 |
| K844003 | ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH | Electro-Catheter Corp. | 1984-12-27 | 76 | 0 |
| K843983 | MYOCARDIAL INSULATOR | Norton Texas Medical Products | 1984-12-27 | 77 | 0 |
| K843860 | OXYSCREEN | Erich Jaeger, Inc. | 1984-12-27 | 87 | 0 |
| K843798 | MEADOX SURGIMED A/S CATHETER SHEATH SYS | Meadox Surgimed, Inc. | 1984-12-27 | 91 | 0 |
| K843320 | RT-50 | General Electric Co. | 1984-12-27 | 125 | 0 |
| K843376 | ECG PATIENT MONITOR | Rigel Medical Electronics, Inc. | 1984-12-27 | 121 | 0 |
| K844139 | STOCKERT-SHILEY INTRACARDIAC SUCKERS | Shiley, Inc. | 1984-12-27 | 65 | 0 |
| K842218 | ANTI-LEU-4 FITC LYSIN C BUFFER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-12-27 | 206 | 0 |
| K811259 | CORDIS ENCOR ATRIAL LEAD | Cordis Corp. | 1984-12-27 | 1331 | 0 |
| K843802 | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | Shiley, Inc. | 1984-12-27 | 91 | 0 |
| K844100 | CANMED 101 | Medtronic Vascular | 1984-12-27 | 65 | 0 |
| K844099 | CANMED 102 | Medtronic Vascular | 1984-12-27 | 65 | 0 |
| K843706 | MEDTRONIC 6957 | Medtronic Vascular | 1984-12-27 | 97 | 0 |
| K843398 | OSTEOGEN | Impladent | 1984-12-27 | 120 | 0 |
| K844256 | NELLCOR PULSE OXIMETER N-10 | Nellcor, Inc. | 1984-12-27 | 55 | 0 |
| K844140 | STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH | Shiley, Inc. | 1984-12-27 | 65 | 0 |
| K844138 | STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI | Shiley, Inc. | 1984-12-27 | 65 | 0 |
| K844666 | SITE ULTRASONIC EMULSIFICATION MODULE OP | Chiron Vision Corp. | 1984-12-27 | 27 | 0 |
| K844197 | ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS | Nidek, Inc. | 1984-12-24 | 55 | 0 |
| K844903 | MIC-BIO-PLATE | Pasco Laboratories, Inc. | 1984-12-24 | 10 | 0 |
| K844312 | ME-TOO OXYGEN CONCENTRATOR | Medequip Co. | 1984-12-24 | 48 | 0 |
| K844198 | ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE | Nidek, Inc. | 1984-12-24 | 55 | 0 |
| K844223 | PREMIER O2 OXYGEN CONCENTRATOR | Everest & Jennings, Inc. | 1984-12-24 | 53 | 0 |
| K843486 | VIBRAMETER | Somedic AB | 1984-12-24 | 109 | 0 |
| K844496 | MEDIPART XENON BREATHING KIT MP-01XM | Medipart Jerry Alexander | 1984-12-24 | 34 | 0 |
| K844761 | SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD | Medical Instrument Development Laboratories, Inc. | 1984-12-24 | 17 | 0 |
| K843550 | ORTHOMAG MAGNETIC FORCE SYSTEM | Medical Magnetics, Inc. | 1984-12-21 | 102 | 0 |
| K844351 | OPTI-LITE | Innovators, Inc. | 1984-12-21 | 42 | 0 |
| K843131 | ACCESS & 72X ULTRASOUND SCANHEAD UM4 | Advanced Technology Laboratories, Inc. | 1984-12-20 | 133 | 0 |
| K842559 | WHITESIDE ORTHOLOC TOTAL HIP FEMORAL | Dow Corning Corp. Healthcare Industries Materials | 1984-12-20 | 171 | 0 |
| K843165 | ULTRASOUND 72X & ANNULAR ARRAY SCAN- | Advanced Technology Laboratories, Inc. | 1984-12-20 | 129 | 0 |
| K844273 | AUTORANGING DIGITAL THERMOMETER | Micro Idea Instrument Co., Ltd. | 1984-12-20 | 45 | 0 |
| K843391 | INFUSION ASPIRATION VITRECTOMY SYS | Medical Instrument Development Laboratories, Inc. | 1984-12-19 | 112 | 0 |
| K842793 | MVS XII | Medical Instrument Development Laboratories, Inc. | 1984-12-19 | 155 | 0 |
| K844611 | SINGLE BASIN SET | Packaging Technologies, Inc. | 1984-12-19 | 22 | 0 |
| K843885 | PERCUTANEOUS ASPIRATION BIOPSY TRAY | Applied Medical Devices, Inc. | 1984-12-19 | 78 | 0 |
| K844255 | GENT-L-KARE STERILE I.V. START KIT | Geneva Laboratories, Inc. | 1984-12-19 | 47 | 0 |
| K842339 | COMPUSTRESS STRESS TESTING SYS | Intl. Medical, Inc. | 1984-12-19 | 189 | 0 |
| K844053 | CANON 60 DEGREE FUNDUS CAMERA CF-60S | Canon USA, Inc. | 1984-12-19 | 62 | 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