Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1987 — Predicate Candidate Screening
4,160 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
56 daysmedian FDA review time
139 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873626 | FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM | Orthopedic Systems, Inc. | 1987-12-31 | 114 | 0 |
| K873970 | KIRSCHNER UNICONDYLAR KNEE SYSTEM | Kirschner Medical Corp. | 1987-12-31 | 93 | 0 |
| K874062 | ENTERON LIVER BIOPSY TRAY | Endovations | 1987-12-31 | 87 | 0 |
| K874081 | ENTERSCAN | Pie Data Medical BV | 1987-12-31 | 85 | 0 |
| K874100 | AML CALCAR FEMORAL PROSTHESIS | Depuy, Inc. | 1987-12-31 | 84 | 0 |
| K874742 | QUICKTRACH | Posey Co. | 1987-12-31 | 43 | 0 |
| K873125 | SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR | Rehab Medical Specialties, Inc. | 1987-12-31 | 143 | 0 |
| K874888 | ISOLATION GOWN | Sage Products, Inc. | 1987-12-30 | 29 | 0 |
| K874954 | MANUAL RONGEUR | Solway, Inc. | 1987-12-30 | 28 | 0 |
| K874952 | MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIES | Solway, Inc. | 1987-12-30 | 28 | 0 |
| K874479 | MC/CPAP MANIFOLD | Minneapolis Children'S Services Corp. | 1987-12-30 | 58 | 0 |
| K870899 | EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX | Biosound, Inc. | 1987-12-30 | 300 | 0 |
| K874961 | BONE CUTTING INSTRUMENTS & ACCESSORIES | Solway, Inc. | 1987-12-30 | 28 | 0 |
| K874889 | U.V. SUNLAMP 95 UF-11 | Light Sources, Inc. | 1987-12-30 | 29 | 0 |
| K874513 | MONAGHAN AEROCHAMBER WITH MASK | Monaghan Medical Corp. | 1987-12-30 | 58 | 0 |
| K874386 | CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1987-12-30 | 65 | 0 |
| K874653 | STERILE SURGICAL SCRUB BRUSH | Surgikos, Inc. | 1987-12-30 | 47 | 0 |
| K874000 | PRIA-KIT (TM) PRIAPISM KIT S.S. | Canton Medical, Inc. | 1987-12-30 | 90 | 0 |
| K874437 | TRAUMA-TRODE, ECG ELECTRODE (597 ADHESIVE) | Labeltape Meditect, Inc. | 1987-12-30 | 63 | 0 |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Pall Biomedical Products Co. | 1987-12-30 | 63 | 0 |
| K874184 | CHEMO-PORT | Hdc Corp. | 1987-12-30 | 77 | 0 |
| K874959 | VASCULAR CLAMP | Solway, Inc. | 1987-12-30 | 28 | 0 |
| K873166 | BCM DRY PACK BICARBONATE MIXER | Specialty Dialysis Services | 1987-12-30 | 141 | 0 |
| K874446 | MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL) | 3M Company | 1987-12-30 | 63 | 0 |
| K874880 | COLORED CASTING TAPE CARAGLAS(TM GREEN | Synthetic Mfg., Inc. | 1987-12-30 | 29 | 0 |
| K872352 | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA | Laser Media | 1987-12-30 | 196 | 0 |
| K873627 | CTI STRAIGHT STEM | Orthopedic Systems, Inc. | 1987-12-30 | 113 | 0 |
| K873248 | GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS | Medical Engineering Laboratory, Inc. | 1987-12-30 | 138 | 0 |
| K874928 | WHOLEY (TM) BIOPSY DEVICE | Medrad, Inc. | 1987-12-30 | 28 | 0 |
| K873495 | PUMP TUBING SET | Marquette Medical, Inc. | 1987-12-30 | 121 | 0 |
| K873291 | MSI 9000 SERIES BED | Med Service, Inc. | 1987-12-30 | 135 | 0 |
| K874950 | MICROSURGICAL INSTRUMENTS | Solway, Inc. | 1987-12-30 | 28 | 0 |
| K874965 | MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE | Solway, Inc. | 1987-12-30 | 28 | 0 |
| K873579 | AMBU RMT VALVE | Ambu, Inc. | 1987-12-30 | 118 | 0 |
| K874032 | IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 | Diagnostic Products Corp. | 1987-12-30 | 89 | 0 |
| K874378 | DINAMAP VITAL SIGNS MONITOR, MODEL 8100T | Critikon Company, LLC | 1987-12-30 | 65 | 0 |
| K874022 | PHARMASEAL WOUND IRRIGATION DEVICE | American Pharmaseal Div. Ahsc | 1987-12-30 | 89 | 0 |
| K873605 | COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE | Pain Prevention Laboratory, Inc. | 1987-12-30 | 117 | 0 |
| K875021 | ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM | Buckman Co., Inc. | 1987-12-30 | 26 | 0 |
| K873991 | LAKE IRRIGATION TRAY | Lake Medical Products, Inc. | 1987-12-30 | 90 | 0 |
| K874687 | COLLI-MATETM MODEL NO. B800 | Summit Industries, Inc. | 1987-12-30 | 47 | 3 |
| K873494 | RESERVOIR BAG | Marquette Medical, Inc. | 1987-12-30 | 121 | 0 |
| K873859 | CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104 | Datex Division Instrumentarium Corp. | 1987-12-29 | 98 | 0 |
| K873522 | BARD AMBULATORY PCA DRUG DELIVERY SYSTEM | C.R. Bard, Inc. | 1987-12-29 | 119 | 0 |
| K874294 | AUTOCHUCK ATTACHMENT | Den-Tal-Ez Mfg Co., Inc. | 1987-12-29 | 70 | 0 |
| K874158 | CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. | Cardiac Control Systems, Inc. | 1987-12-29 | 77 | 0 |
| K874632 | BENT NECK CURLCATH PERITONEAL DIALYSIS KIT | Quinton, Inc. | 1987-12-29 | 50 | 0 |
| K874335 | EXPLORER-DENTAL PROBER | Military Engineering, Inc. | 1987-12-29 | 68 | 0 |
| K873961 | INFUMED 300 AMBULATORY INFUSION PUMP | Med Fusion Systems, Inc. | 1987-12-29 | 91 | 0 |
| K873920 | BR-2 BIOREST | Biorest, Inc. | 1987-12-29 | 95 | 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