Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1982 — Predicate Candidate Screening
3,408 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
30 daysmedian FDA review time
78 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823664 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823238 | INJECTION FILL TUBE | Vetrex Medical Corp. | 1982-12-30 | 59 | 0 |
| K823626 | DISPOSABLE TOOTH BRUSH | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823500 | CHOLESTEROL REAGENT | Ac Biochemical Laboratories, Inc. | 1982-12-30 | 36 | 0 |
| K823765 | ANTI SERA TO HUMAN OROSCOMUCOID | Kent Laboratories, Inc. | 1982-12-30 | 16 | 0 |
| K823665 | ROTATION BOOT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR | Burditt & Calkins-Siemens-Elema | 1982-12-30 | 44 | 0 |
| K822467 | PERFILM MEMBRANE DRESSING | Chesebrough-Pond'S U.S.A. Co. | 1982-12-30 | 136 | 0 |
| K822240 | ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. | American Mcgaw | 1982-12-30 | 156 | 0 |
| K822810 | PHADEBACT CSF TEST 20 | Pharmacia, Inc. | 1982-12-30 | 101 | 0 |
| K823272 | VENOUS RESERVOIR BAG #BMR-1400 | Bentley Laboratories, Inc. | 1982-12-30 | 58 | 0 |
| K823253 | VERTEX MONITORING CATHETER | Vertex Medical Corp. | 1982-12-30 | 59 | 0 |
| K823662 | RIB BELT (UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823584 | FUKUDA DENSHI 6-CHANNEL AUTO. ELECTRO- | Brentwood Instruments, Inc. | 1982-12-30 | 24 | 0 |
| K823660 | UNIVERSAL BUCKS TRACTION | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823190 | BACKSTOP VALVE W/SIDE ARM | Vertex Medical Corp. | 1982-12-30 | 65 | 0 |
| K823488 | ELECTROCARDIOGRAPH #334 | Birtcher Corp. | 1982-12-30 | 37 | 0 |
| K823663 | ABDOMINAL BINDER | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823625 | MOUTH STICK KIT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823667 | CERVICAL COLLAR | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823661 | CLAVICLE SUPPORT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823583 | MYOTEST NERVE STIMULATOR | Prothia USA, Inc. | 1982-12-30 | 24 | 0 |
| K823290 | NEUROMEDICS PACETRON HEART RATE MONITOR | Intermedics, Inc. | 1982-12-30 | 55 | 0 |
| K823516 | ESA CAMERA | Concept, Inc. | 1982-12-30 | 31 | 0 |
| K823608 | PICTURES & WORD IDENTIFICATION CVA PAT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823197 | MODEL 8300 TESTER | Medicon, Inc. | 1982-12-30 | 65 | 0 |
| K823340 | CLEAR VINYL MONITORING CONNECTOR | Vertex Medical Corp. | 1982-12-30 | 52 | 0 |
| K823414 | HOLTER KIT MODEL #5000 SERIES | Andover Medical, Inc. | 1982-12-30 | 45 | 0 |
| K823474 | ENZYMATIC GLUCOSE DETERMINATION | The Dow Chemical Co. | 1982-12-30 | 38 | 0 |
| K823033 | ELECTRODE, PACEMAKER, PERMANENT | Pacesetter Systems | 1982-12-30 | 77 | 0 |
| K823192 | TUOHY-BORST ADAPTER W/SIDE ARM | Vertex Medical Corp. | 1982-12-30 | 65 | 0 |
| K823624 | HOLDER FOR MOUTH STICK | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823469 | TERUFUSION THREE-WAY STOPCOCK | Terumo Medical Corp. | 1982-12-30 | 38 | 0 |
| K823659 | PELVIC TRACTION BELT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823254 | REUSABLE METAL STOPCOCK | Vertex Medical Corp. | 1982-12-30 | 59 | 0 |
| K823286 | MODELS DPT 1000/DPT 1000NS | Bio-Med Corp. | 1982-12-30 | 56 | 0 |
| K822944 | GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT | Travenol Laboratories, S.A. | 1982-12-30 | 87 | 0 |
| K823629 | FORMED STEEL DEVICE KEEP LEGS SEPARATED | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823622 | INSULATED THERMOELASTOMER MITT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K822818 | HOLTER RECORDER & PLAYBACK/ANALYSIS SYS | Marquette Electronics, Inc. | 1982-12-30 | 101 | 0 |
| K823456 | OXYGENATORS #BOS-10, 105, 5S | Bentley Laboratories, Inc. | 1982-12-30 | 42 | 0 |
| K823533 | JACKET & SET | Shiley, Inc. | 1982-12-30 | 31 | 0 |
| K823373 | BENZING RETROGRADE ADMIN. SET | Beech Medical, Inc. | 1982-12-30 | 48 | 0 |
| K823567 | IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM | Syva Co. | 1982-12-30 | 27 | 0 |
| K823658 | DELUXE KNEE IMMOBILIZER(UNIVERSAL) | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823666 | UNIVERSAL WRIST SPLINT & FOREARM SPLINT | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823256 | ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE | Vertex Medical Corp. | 1982-12-30 | 59 | 0 |
| K823191 | DISPOSABLE PLASTIC STOPCOCK | Vertex Medical Corp. | 1982-12-30 | 65 | 0 |
| K823566 | IMMUNOGLOBULIN CONTROL | Syva Co. | 1982-12-30 | 27 | 0 |
| K823612 | ADJ. WOODEN BOARD FOR WRITING | Fred Sammons, Inc. | 1982-12-30 | 24 | 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