Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1996 — Predicate Candidate Screening
4,407 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
86 daysmedian FDA review time
273 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964006 | INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES) | Hollister, Inc. | 1996-12-31 | 85 | 0 |
| K963951 | AS 123 PROSTHETIC INSTRUMENTATION SYSTEM | BioHorizons Implant Systems, Inc. | 1996-12-31 | 90 | 3 |
| K964016 | TIELLE HYDROPOLYMER FOAM DRESSING | Johnson & Johnson Medical, Inc. | 1996-12-31 | 85 | 0 |
| K964127 | MEDI-VAC FLEXI-CLEAR SUCTION HANDLE | Allegiance Healthcare Corp. | 1996-12-31 | 77 | 0 |
| K964411 | TAKI ACUPUNCTURE NEEDLES | Lhasa Medical, Inc. | 1996-12-31 | 83 | 0 |
| K964134 | TRUS<T>LIFT PORCH LIFT | Trus T Lift | 1996-12-31 | 77 | 0 |
| K964515 | ACCLAIM SERIES QD6000,QD6001,QD6002 AND SERIES QD3000,QD3001 | M.C. Healthcare Products, Inc. | 1996-12-31 | 76 | 0 |
| K964057 | INCARE HOT/ICE SYSTEM SHOULDER BLANKET | Hollister, Inc. | 1996-12-31 | 83 | 0 |
| K963184 | OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM | Olympus America, Inc. | 1996-12-31 | 139 | 0 |
| K964070 | DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG | Deknatel, Inc. | 1996-12-31 | 82 | 0 |
| K964145 | ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 | Crystal Mark, Inc. | 1996-12-31 | 75 | 0 |
| K955425 | DASH, SULLIVAN, VITAL GARD HYPOALLERGENIC WITH PROTEIN CONTE | Dash Medical Gloves Sdn Bhd | 1996-12-30 | 398 | 0 |
| K955661 | ACU-HALT | Glederer & Co., Inc. | 1996-12-30 | 384 | 0 |
| K964563 | OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE | Omni Sales Corp. | 1996-12-30 | 46 | 0 |
| K961342 | SHOE COVER, NON-STERILE | Copioumed Intl., Inc. | 1996-12-30 | 285 | 0 |
| K964120 | INJECTO FLUSH | Robert J. Jynch, Jr. | 1996-12-30 | 76 | 0 |
| K960999 | ISOLATION GOWN | Copioumed Intl., Inc. | 1996-12-30 | 293 | 0 |
| K964545 | POWDER FREE VINYL EXAMINATION GLOVE | Shanghai Poseidon Plastic Products Co., Ltd. | 1996-12-30 | 47 | 0 |
| K964177 | KROMALGIN IMPRESSION MATERIAL | North American Orthodontic Laboratories, Inc. | 1996-12-30 | 73 | 0 |
| K964163 | TRIMAX NAIL SYSTEM | Smith & Nephew Richards, Inc. | 1996-12-27 | 71 | 0 |
| K964262 | EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD | Exactech, Inc. | 1996-12-27 | 63 | 0 |
| K962309 | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | Althin Medical AB an Affiliate of Baxter Intl | 1996-12-27 | 193 | 0 |
| K963985 | UM-D3000/UM-D4000 | J.J. Consulting Services, Inc. | 1996-12-27 | 84 | 0 |
| K962486 | DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM | Depuy, Inc. | 1996-12-27 | 184 | 0 |
| K953111 | CORAIL | Landos, Inc. | 1996-12-27 | 543 | 0 |
| K964150 | WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1996-12-27 | 72 | 0 |
| K964008 | FOUNDATION KNEE SYSTEM | Encore Orthopedics, Inc. | 1996-12-27 | 81 | 0 |
| K961992 | NEEDLE'S EYE SNARE | Cook Pacemaker Corp. | 1996-12-27 | 220 | 0 |
| K962435 | STC AUTO-LYTE URINARY GLUCOSE ASSAY | OraSure Technologies, Inc. | 1996-12-26 | 185 | 0 |
| K962037 | IMAGEN RESPIRATORY SCREEN | Dako Diagnostics , Ltd. | 1996-12-26 | 216 | 0 |
| K961405 | ALBA HEALTH PAS WRAP SYSTEM | Alba-Waldensian, Inc. | 1996-12-26 | 259 | 1 |
| K964669 | MIRACLE-EAR OR AUDIOTONE | Miracle-Ear, Inc. | 1996-12-26 | 35 | 0 |
| K963938 | MODEL 5500 CEAS | Esa, Inc. | 1996-12-26 | 86 | 0 |
| K962418 | UREA NITROGEN (BUN) LIQUI-UV | Stanbio Laboratory | 1996-12-26 | 185 | 0 |
| K964637 | CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDI | Medical Packaging Corp. | 1996-12-24 | 35 | 0 |
| K964060 | COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINIST | Travenol Laboratories (Israel) , Ltd. | 1996-12-24 | 76 | 0 |
| K963972 | NEO-CARE DUAL LUMEN UMBILICAL CATHETER | Klein-Baker Medical, Inc. | 1996-12-24 | 82 | 0 |
| K961780 | HEMODIALYSIS INTRODUCER SET | Thomas Medical Products, Inc. | 1996-12-24 | 230 | 0 |
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORM | Nichols Institute Diagnostics | 1996-12-24 | 175 | 1 |
| K960915 | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | Clarus Medical Systems, Inc. | 1996-12-24 | 293 | 0 |
| K963847 | WAKO DIRECT HDL-C | Wako Chemicals USA, Inc. | 1996-12-24 | 90 | 0 |
| K961209 | BRIO AUTOMATIC SAMPLINC UNIT | Seac S.R.L. | 1996-12-24 | 271 | 0 |
| K964116 | QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO | Bayer Corp. | 1996-12-24 | 70 | 0 |
| K964376 | CIDE-SWIPES P-100B & CIDE-SWIPES C-100A | Mp Scientific, Inc. | 1996-12-23 | 52 | 0 |
| K963699 | BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY | Belmont Equipment Corp. | 1996-12-23 | 98 | 0 |
| K963980 | PHILIPS EASYVISION | Philips Medical Systems North America, Inc. | 1996-12-23 | 81 | 1 |
| K962226 | PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM | Johnson & Johnson Medical, Inc. | 1996-12-23 | 196 | 0 |
| K964453 | REP 3 FLUR SPE-60 KIT | Helena Laboratories | 1996-12-23 | 47 | 0 |
| K960854 | SIEMENS SERVO ULTRA NEBULIZER 345 | Pacesetter, Inc. | 1996-12-23 | 297 | 0 |
| K962093 | ULTRAMIX | Sonotech, Inc. | 1996-12-23 | 208 | 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