Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1981 — Predicate Candidate Screening
3,287 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
26 daysmedian FDA review time
77 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K813082 | UREOFIX 500 URINE MEASURING SYSTEM | Burron Medical Products, Inc. | 1981-12-31 | 59 | 0 |
| K813441 | PIPERACILLIN 100 MCG. SENSI DISC | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-12-31 | 21 | 0 |
| K813529 | DADE COLORIMETRIC AMYLASE | American Dade | 1981-12-31 | 14 | 0 |
| K813494 | WATERS ILEAL RESERVOIR CATHETER | Waters Instruments, Inc. | 1981-12-31 | 17 | 0 |
| K813428 | SHUNT ADAPTER | Quinton, Inc. | 1981-12-31 | 23 | 0 |
| K813403 | FLO-GARD 8000 INFUSION PUMP SYSTEM | Travenol Laboratories, S.A. | 1981-12-31 | 24 | 0 |
| K813412 | GLUCOSE ENZYME-COLOR REAGENT SET | Diagnostic Specialties | 1981-12-31 | 27 | 0 |
| K813407 | AIR MATTRESS | Trans World Agency, Inc. | 1981-12-31 | 24 | 0 |
| K813495 | ALT (SGPT) | Pointe Scientific, Inc., | 1981-12-31 | 17 | 0 |
| K813447 | SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR | Rna Medical Corp. | 1981-12-31 | 30 | 0 |
| K813540 | A FLUOROMETER | American Diagnostic Corp. | 1981-12-31 | 10 | 0 |
| K813006 | MODEL TDS-2450-2 MICROWAVE DIATHERMY SYS | Technology Applications Group | 1981-12-31 | 65 | 0 |
| K813415 | UREA NITROGEN REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-31 | 24 | 0 |
| K813505 | FLAME PHOTOMETER CALIBRATION STANDARDS | Fisher Scientific Co., LLC | 1981-12-31 | 16 | 0 |
| K813536 | ASTRA TOTAL PROTEIN REAGENT | Hi Chem, Inc. | 1981-12-31 | 13 | 0 |
| K813383 | DISPOSABLE TRACH SWIVEL CONNECTOR | Intec. | 1981-12-31 | 29 | 0 |
| K813414 | PEAK FLOW MONITOR | Biotrine Corp. | 1981-12-31 | 24 | 0 |
| K813538 | PHENYTOIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1981-12-31 | 10 | 0 |
| K813359 | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | American Scientific Products | 1981-12-31 | 31 | 0 |
| K813449 | PHE/TYR KINETIC UV TEST SET | P-L Biochemicals, Inc. | 1981-12-31 | 21 | 0 |
| K813523 | ELECTRIC SELF STERILIZATION INOCUL. LOOP | Techhnilab Instruments, Inc. | 1981-12-31 | 15 | 0 |
| K813260 | TRACHEOSTOMY CARE TRAY | E.M. Adams | 1981-12-31 | 41 | 0 |
| K813092 | ACCUPRO I.V. ADMINISTRATION SET | American Mcgaw | 1981-12-31 | 59 | 0 |
| K813208 | K60 HABITAT ENVIRONMENT ENCLOSURE | Kohler | 1981-12-31 | 43 | 0 |
| K813496 | LDH-L | Pointe Scientific, Inc., | 1981-12-31 | 17 | 0 |
| K813539 | GENTAMICIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1981-12-31 | 10 | 0 |
| K813164 | SYSTEK #1 EIKEN | Syn-Kit, Inc. | 1981-12-31 | 51 | 0 |
| K813202 | THERMALOG S STEAM STERILIZATION INTEGRA | Bio-Medical Sciences, Inc. | 1981-12-31 | 48 | 0 |
| K813513 | AFRICAN GREEN MONKEY BLOOD IN ALSERVERS | Dutchland Laboratories, Inc. | 1981-12-31 | 16 | 0 |
| K813525 | IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY | Micromedic Systems | 1981-12-31 | 15 | 0 |
| K813427 | ULTRACHEM GLUC-DH | Harleco | 1981-12-31 | 24 | 0 |
| K813333 | ALPHATEMP CLINICAL THERMOMETER | Alpha Omega Engineering Corp. | 1981-12-31 | 37 | 0 |
| K813469 | LIPID PROFILE | Bio-Analytics Laboratories, Inc. | 1981-12-31 | 20 | 0 |
| K813243 | CERAL-BASE METAL ALLOY | Sillard Products, Inc. | 1981-12-31 | 43 | 0 |
| K813316 | CUSTOM-IN-THE-EAR HEARING AID | Telesonic, Inc. | 1981-12-31 | 37 | 0 |
| K813517 | BLOOD GAS ANALYSIS, STANDARDS CONTROLS | United Diagnostics, Inc. | 1981-12-31 | 15 | 0 |
| K812858 | CHEMFIL | Dentsply Intl. | 1981-12-31 | 79 | 0 |
| K813524 | CENTIDISC | Bel-Art Products | 1981-12-31 | 15 | 0 |
| K813351 | NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER | Novametrix Medical Systems, Inc. | 1981-12-31 | 34 | 0 |
| K813200 | GDC-1136 CASTING ALLOY FOR PORCELAIN-FU | Ney | 1981-12-31 | 48 | 0 |
| K813273 | EMERGENCY POWER PAC (EMPAC) | Optical Micro Systems, Inc. | 1981-12-31 | 41 | 0 |
| K813189 | PHADEBAS/PHADEZYM IGE REAGENTS | Pharmacia, Inc. | 1981-12-31 | 45 | 0 |
| K812988 | AGGLUTEX BARBITURATES TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-31 | 66 | 0 |
| K813084 | CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET | Burron Medical Products, Inc. | 1981-12-31 | 59 | 0 |
| K813259 | IN-STOPPER (INJECTION CAP | Burron Medical Products, Inc. | 1981-12-31 | 41 | 0 |
| K813511 | URIC-ACID | Medical Analysis Systems, Inc. | 1981-12-31 | 16 | 0 |
| K812985 | AGGLUTEX MORPHINE TEST KIT | Hoffmann-La Roche, Inc. | 1981-12-31 | 66 | 0 |
| K813248 | DENTAL FLOSS HOLDER | Sewon Industry | 1981-12-31 | 42 | 0 |
| K813074 | CONNECTORS & ADAPTERS | Seven Harvest Intl. Import & Export | 1981-12-31 | 59 | 0 |
| K813487 | CATHETER BUBBLE STAND | Accurate Surgical Instruments Co. | 1981-12-31 | 30 | 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