Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1992 — Predicate Candidate Screening
3,665 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
122 daysmedian FDA review time
294 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921090 | ISOLA(R) TRANSVERSE ROD DUAL CONNECTOR | Acromed Corp. | 1992-12-31 | 300 | 0 |
| K920392 | ISOLA SPINE SYSTEM: PLATE-ROD COMBINATION | Acromed Corp. | 1992-12-31 | 336 | 0 |
| K923402 | CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR | Pro-Tech, Inc. | 1992-12-30 | 173 | 0 |
| K914600 | NEUROLOGICAL SPONGE | I M, Inc. | 1992-12-30 | 446 | 0 |
| K924995 | 4 SURE TM ANESTHESIA EXTENSION SET | Boston Pacific Medical, Inc. | 1992-12-30 | 90 | 0 |
| K924719 | ANCOR | Siemens Medical Solutions USA, Inc. | 1992-12-30 | 100 | 0 |
| K924107 | ERCP CANNULA | United States Endoscopy Group, Inc. | 1992-12-30 | 139 | 0 |
| K920880 | BRAINSCAN BRACHYTHERAPY MODULE | Brainlab | 1992-12-30 | 308 | 0 |
| K923161 | BRAIDED POLYESTER SUTURE MATERIAL | Mitek Surgical Products, Inc. | 1992-12-30 | 184 | 0 |
| K924756 | MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL | Siemens Medical Solutions USA, Inc. | 1992-12-30 | 98 | 0 |
| K925491 | BARBITURATE EIA TEST | Diagnostic Reagents, Inc. | 1992-12-30 | 58 | 0 |
| K921608 | PRESSSION, SEQUENTIAL | Chattanooga Group, Inc. | 1992-12-30 | 271 | 0 |
| K926082 | CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT | Biodan Medical Systems, Ltd. | 1992-12-30 | 29 | 0 |
| K924708 | CINENET CARDIAC IMAGE NETWORK | Sony Medical Systems | 1992-12-30 | 103 | 0 |
| K925903 | LAPAROSCOPIC 5MM ABC PROBE, MODIFICATION | Birtcher Medical Systems, Inc. | 1992-12-30 | 48 | 4 |
| K924006 | BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1992-12-29 | 141 | 0 |
| K915073 | MARQUETTE SV O2 MODULE | Marquette Electronics, Inc. | 1992-12-29 | 417 | 0 |
| K921327 | NATURE'S CRADLE HM-10 | Infant Advantage, Inc. | 1992-12-29 | 286 | 0 |
| K921487 | MARQUETTE SERIES 360 DEFIBRILLATOR | Marquette Electronics, Inc. | 1992-12-29 | 274 | 0 |
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Innovative Medical Systems, Inc. | 1992-12-29 | 110 | 0 |
| K924728 | KNOT PUSHER | Advanced Surgical, Inc. | 1992-12-29 | 99 | 0 |
| K924659 | OLYUMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | 1992-12-29 | 105 | 0 |
| K924262 | ENA SCREENING CIE KIT FOR DIAGNOSTIC USE | The Binding Site, Ltd. | 1992-12-29 | 127 | 0 |
| K923878 | BIVONA CUSTOMIZED TRACHEOSTOMY TUBES | Bivona Medical Technologies | 1992-12-29 | 148 | 1 |
| K925171 | FREE SUN PRO DESIGN 3000 AND 3800 | Free Sun Prod. AB | 1992-12-29 | 76 | 0 |
| K921279 | CD4 CYTOSPHERES KIT | Coulter Electronics, Inc. | 1992-12-29 | 287 | 0 |
| K920879 | BRAINSCAN RADIOSURGERY MODULE | Brainlab | 1992-12-29 | 307 | 1 |
| K925335 | ACUFEX INTRA ARTICULAR MEASURING DEVICE | Acufex Microsurgical, Inc. | 1992-12-29 | 68 | 0 |
| K922845 | BASIC DRESSING CHANGE TRAY SMP 102A | Specialty Medical Products Co. | 1992-12-29 | 200 | 0 |
| K924862 | AIA-PACK HCG CALIBRATION VERIFICATION TEST SET | Tosoh Medics, Inc. | 1992-12-28 | 91 | 0 |
| K925436 | MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-12-28 | 61 | 0 |
| K926015 | CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 | Cala Diagnostics | 1992-12-28 | 28 | 0 |
| K925801 | REP E-Z CK-30 ISOENZYME KIT | Helena Laboratories | 1992-12-28 | 42 | 0 |
| K925132 | BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE | Becton Dickinson Advanced Diagnostics | 1992-12-28 | 76 | 0 |
| K924113 | ABUSCREEN ONLINE FOR COCAINE METABOLITE | Roche Diagnostic Systems, Inc. | 1992-12-28 | 137 | 0 |
| K925668 | CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM | E.I. Dupont DE Nemours & Co., Inc. | 1992-12-28 | 48 | 2 |
| K923163 | RUBBER DAM CLAMP | Aseptico, Inc. | 1992-12-28 | 182 | 0 |
| K925586 | DETECTABUSE(TM) | Biochemical Diagnostic, Inc. | 1992-12-28 | 54 | 0 |
| K923438 | BOSTON CONDITIONING SOLUTION | Polymer Technology Corp. | 1992-12-28 | 168 | 0 |
| K925257 | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-12-28 | 70 | 0 |
| K925208 | ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION | Ortho Diagnostic Systems, Inc. | 1992-12-28 | 91 | 0 |
| K924151 | BISCO D/C RESINOMER | Bisco, Inc. | 1992-12-28 | 132 | 0 |
| K924365 | VACUPLUS TUBES WITH BRICK RED STOPPERS | Starplex Scientific, Inc. | 1992-12-28 | 122 | 0 |
| K924020 | ELECTROPHORESIS TANK | The Binding Site, Ltd. | 1992-12-28 | 139 | 0 |
| K923587 | GLUCOSE TEST SYSTEM | Polymer Technology Corp. | 1992-12-28 | 188 | 0 |
| K922171 | CENTRA II ANALYSIS SYSTEM | Marquette Electronics, Inc. | 1992-12-28 | 234 | 0 |
| K913724 | SONEX ULTRASONIC TOOTH BRUSH | Sonex Intl., Corp. | 1992-12-28 | 496 | 0 |
| K925096 | CONCEIVE ONE-STEP PREGNANCY TEST | Quidel Corp. | 1992-12-28 | 81 | 0 |
| K925251 | LIXI IMAGING SCOPE. MODIFICATION | Lixi, Inc. | 1992-12-28 | 73 | 0 |
| K925844 | PHILIPS SUPER CP FAMILY | Philips Medical Systems, Inc. | 1992-12-28 | 40 | 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