Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1995 — Predicate Candidate Screening
5,487 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
94 daysmedian FDA review time
382 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950856 | ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, | Zoll Medical Corp | 1995-12-29 | 305 | 0 |
| K952320 | PYRILINKS-D ASSAY KIT | Metra Biosystems, Inc. | 1995-12-29 | 225 | 0 |
| K954480 | CONDENSATE COLLECTION KIT | Nova-Ventrx | 1995-12-29 | 94 | 0 |
| K955106 | BTE CPM-20 | Baltimore Therapeutic Equipment Co. | 1995-12-29 | 51 | 0 |
| K951593 | LIFEPAK 11 | Physio-Control Corp. | 1995-12-29 | 267 | 1 |
| K955390 | INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY | Corning Nichols Diagnostics | 1995-12-29 | 35 | 0 |
| K954529 | AUTOMATED TRU-CUT BIOPSY DEVICE | Baxter Healthcare Corp | 1995-12-29 | 91 | 0 |
| K955609 | CONVEEN URINE BAG - STERILE | Coloplast Corp. | 1995-12-29 | 21 | 0 |
| K955105 | BTE CPM-10 | Baltimore Therapeutic Equipment Co. | 1995-12-29 | 51 | 0 |
| K954438 | SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE | Rms Div. | 1995-12-29 | 95 | 0 |
| K955142 | DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813 | Salutron, Inc. | 1995-12-29 | 46 | 0 |
| K953877 | MITEK GII ANCHOR | Mitek Surgical Products, Inc. | 1995-12-29 | 165 | 0 |
| K954446 | AUGUSTINE INTUBATION GUIDE | Augustine Medical, Inc. | 1995-12-29 | 95 | 0 |
| K954420 | AXSYM DIGITOXIN | Abbott Laboratories | 1995-12-29 | 99 | 0 |
| K953358 | SURGEONS GLOVE POWDER FREE | American Pro Latex, Inc. | 1995-12-28 | 164 | 0 |
| K955530 | RANIR HI-TECHNOLOGY DENTAL FLOSS | Ranir/Dcp Corp. | 1995-12-28 | 24 | 0 |
| K955465 | DEGUPRINT | Degussa Corp. | 1995-12-28 | 28 | 0 |
| K954641 | ENDO-LEADER | Microsurge, Inc. | 1995-12-28 | 79 | 0 |
| K953936 | ATLANTIS | Trophy Radiologie | 1995-12-28 | 129 | 0 |
| K946219 | POP-N-LOK SYRINGE | Retractable Technologies, Inc. | 1995-12-28 | 372 | 0 |
| K943106 | ADULT VENTILATOR | Infrasonics Corp. | 1995-12-28 | 547 | 0 |
| K954595 | CORDIS BRITE TIP SHEATH INTRODUCER | Cordis Corp. | 1995-12-28 | 86 | 1 |
| K952787 | FOAM INSTRUMENT GUARD | Oxboro Medical Intl., Inc. | 1995-12-28 | 192 | 0 |
| K954915 | FLEXIBLE INTRAMEDULLARY REAMER | Zimmer, Inc. | 1995-12-28 | 63 | 0 |
| K955509 | MIDAS GOLD ELECTROFORMING SYSTEM | Austenal, Inc. | 1995-12-28 | 24 | 0 |
| K954964 | AQUACENTER 2000 SYSTEM | Aquarius Medical Corp. | 1995-12-28 | 59 | 0 |
| K955279 | D-SENSE | Centrix, Inc. | 1995-12-28 | 42 | 0 |
| K952494 | DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 1995-12-28 | 212 | 0 |
| K922600 | FUTREX-5000 | Futrex, Inc. | 1995-12-28 | 1304 | 0 |
| K950555 | J SINGLE USE HEAD AND JD REUSABLE HANDLE | Micro-Mega Societe Anonyme | 1995-12-28 | 324 | 0 |
| K954314 | ULTRAFIT LINERS | Stahmer Weston Scientific | 1995-12-28 | 104 | 0 |
| K955406 | SCAN WHITE 12 ML | Vident | 1995-12-28 | 31 | 0 |
| K954546 | BLOOD GAS MIXTURE | Liquid Technology Corp. | 1995-12-28 | 90 | 0 |
| K954271 | WESTMED CONDESATE COLLECTION TRAP | Westmed Intl. | 1995-12-28 | 107 | 0 |
| K945774 | BETA FEMORAL HIP STEM | Wrightmedicaltechnologyinc | 1995-12-28 | 398 | 0 |
| K954637 | AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELI | American Dental Products, Inc. | 1995-12-28 | 83 | 0 |
| K922601 | FUTREX-5000A | Futrex, Inc. | 1995-12-28 | 1304 | 0 |
| K952731 | TOWNLEY ALL POLY ACETABULAR CUP | Biologically Oriented Prostheses | 1995-12-28 | 196 | 0 |
| K941627 | A&D UN-231 ULTRASONIC HANDY NEBULIZER | A & D Corporate | 1995-12-28 | 633 | 0 |
| K942977 | NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE | Novoste Corp. | 1995-12-28 | 556 | 0 |
| K954855 | POWDER FREE PLUS PATIENT EXAMINATION GLOVE | Tillotson Healthcare Corp. | 1995-12-28 | 66 | 0 |
| K954275 | MEPORE PLUS (9X15CM) | Scott Health Care | 1995-12-27 | 105 | 0 |
| K951910 | ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES | Xintec Corporation | 1995-12-27 | 247 | 0 |
| K953538 | RM001 REUSABLE | American Optisurgical, Inc. | 1995-12-26 | 151 | 0 |
| K954551 | DF-1 TERMINAL CAP | Pacesetter, Inc. | 1995-12-26 | 85 | 0 |
| K954392 | HYTEC AUTOIMMUNE KIT (SS-A) | Hycor Biomedical, Inc. | 1995-12-26 | 98 | 0 |
| K954891 | HYTEC AUTOIMMUNE KITS (SS-B) | Hycor Biomedical, Inc. | 1995-12-26 | 98 | 0 |
| K954890 | HYTEC AUTOMMUNE KIT (ENA) | Hycor Biomedical, Inc. | 1995-12-26 | 62 | 0 |
| K953539 | DM001 DISPOSABLE PACK | American Optisurgical, Inc. | 1995-12-26 | 151 | 0 |
| K950621 | BIOFILL BIOCELLULOSE DRESSING STERILE | The Purdue Frederick Co. | 1995-12-26 | 319 | 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