Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
1983 — Predicate Candidate Screening
3,564 FDA 510(k) clearances under this clearance year; the 50 most recent screened below.
59 daysmedian FDA review time
128 days90th percentile
2,000clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833968 | 10B | Remel Co. | 1983-12-30 | 44 | 0 |
| K834008 | SABOURAUD DEXTROSE AGAR | Micro Media Laboratories | 1983-12-30 | 39 | 0 |
| K834022 | PVP IODINE | Remel Co. | 1983-12-30 | 38 | 0 |
| K833641 | IMAGE INTENSIFIER TUBE W/HOUSING & | Varian Assoc., Inc. | 1983-12-30 | 74 | 0 |
| K833963 | HAEMOPHILUS IDENTIFICATION TEST KIT | Remel Co. | 1983-12-30 | 44 | 0 |
| K834028 | BIO-ORNITHINE | Remel Co. | 1983-12-30 | 38 | 0 |
| K833083 | DERMA STRIP-TM SKIN CLOSURES | Howmedica Corp. | 1983-12-30 | 109 | 0 |
| K834029 | BIO-UREA | Remel Co. | 1983-12-30 | 38 | 0 |
| K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK | General Diagnostics | 1983-12-30 | 71 | 0 |
| K833232 | LASER PROTECTIVE EYESHIELD | Stefanovsky & Assoc. | 1983-12-30 | 115 | 0 |
| K833826 | BTI BIOX III OXIMETER CRITICAL CAREUNI | Biox Technology, Inc. | 1983-12-30 | 65 | 0 |
| K833407 | SELECTO-DISC NOVOBIOCIN 5UG | Lab Ability, Inc. | 1983-12-30 | 91 | 0 |
| K832965 | STRATUS THEOPHYLLINE ASSAY | American Dade | 1983-12-30 | 120 | 0 |
| K833693 | TEE ADAPTER 9890-FLUSH WINDING 282 | Shaban Mfg. Co. | 1983-12-30 | 73 | 0 |
| K833729 | ELASTIC BREATHABLE OVER-WRAP BANDAGE | American Medical Disposable, Inc. | 1983-12-30 | 66 | 0 |
| K831936 | PRE-ROLLED TUBULAR STOCKINETTE | Ormed Mfg., Inc. | 1983-12-30 | 198 | 0 |
| K833655 | GILLETTE SABRE SYRINGE | Intermedics, Inc. | 1983-12-29 | 70 | 0 |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | Nuclear Diagnostics, Inc. | 1983-12-29 | 69 | 0 |
| K833278 | C & B 45 | Genesis Industries, Inc. | 1983-12-29 | 98 | 0 |
| K833776 | QEA SODIUM/POTASSIUM ANALYZER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-12-29 | 63 | 0 |
| K833596 | GDC 1448 DEVELOPMENT NAME | Deringer-Ney, Inc. | 1983-12-29 | 78 | 0 |
| K833736 | GOLD-PALLADIUM-SILVER BASED CAST/ALLOY | Jeneric Ind. | 1983-12-29 | 65 | 0 |
| K834089 | COMFIT | Ackrad Laboratories | 1983-12-29 | 31 | 0 |
| K833120 | ONE TIME COMPOUND BENZOIN TINCTURE- | Acme United Corp. | 1983-12-29 | 107 | 0 |
| K833598 | LEBLOND DIAMOND DENTAL BUR | A & M Instruments, Inc. | 1983-12-29 | 78 | 0 |
| K833768 | C. PTH RADIOIMMUNOASSAY KIT-CPTHK | Sorin Biomedica, Fiat, USA, Inc. | 1983-12-29 | 63 | 0 |
| K833953 | ELECTRONIC GRAVITY 300VC | Ivent Corp. | 1983-12-29 | 43 | 0 |
| K834131 | SCENTED MENSTRUAL PAD | Procter & Gamble Mfg. Co. | 1983-12-29 | 28 | 0 |
| K833266 | ACRA-CUT | Acra Cut, Inc. | 1983-12-29 | 99 | 0 |
| K833535 | POTASSIUM SODIUM ANALYSIS PRODUCTS | Shaban Mfg. Co. | 1983-12-29 | 93 | 0 |
| K833434 | CERAMCO * HIGH FUSING FOIL SOLDER | Johnson & Johnson Professionals, Inc. | 1983-12-29 | 85 | 0 |
| K833079 | CENTRACATH #130,135 & 137-HEMOCATH # | Exco, Inc. | 1983-12-29 | 111 | 0 |
| K831507 | LOW TRAUMA ARTERIAL FILTER H-640 | C.R. Bard, Inc. | 1983-12-29 | 232 | 0 |
| K831849 | PLEURAL DRAINAGE SYS #PDS-100-4 | American Bentley | 1983-12-29 | 204 | 0 |
| K834144 | UNSCENTED MENSTRUAL PAD | Procter & Gamble Mfg. Co. | 1983-12-29 | 28 | 0 |
| K833958 | FLO-GARD 8100 INFUSION PUMP | Travenol Laboratories, S.A. | 1983-12-29 | 43 | 0 |
| K834281 | RAD II SIMULATOR | Haynes Radiation Ltd., Inc. | 1983-12-29 | 57 | 0 |
| K832284 | SOLUTION ADMIN. SET 2C9096 W/10 PVC | Travenol Laboratories, S.A. | 1983-12-29 | 169 | 2 |
| K832802 | USE OF TWEEN 80 AS A WETTING AGENT ON | American Bentley | 1983-12-29 | 133 | 0 |
| K833484 | COMPUTED TOMOGRAPHY ORIENTED ROTARY ARC | A. Patil, M.D. | 1983-12-29 | 83 | 0 |
| K833718 | ETCHING GEL | Johnson & Johnson Professionals, Inc. | 1983-12-29 | 66 | 0 |
| K832005 | JP-2 RESPIRATORY MONITORING SYSTEM | Morgan Associates, Inc. | 1983-12-29 | 189 | 0 |
| K833941 | ORION | Cgr Medical Corp. | 1983-12-29 | 44 | 0 |
| K834128 | GLOBE RES-Q-FLO | Globe Safety Equipment, Inc. | 1983-12-29 | 30 | 0 |
| K833673 | ACCURATE MEASUREMENT DEVICE EZ-AMD | Sorensen Research | 1983-12-29 | 72 | 0 |
| K833932 | SYVA ADVANCE CORTISOL ASSAY | Syva Co. | 1983-12-29 | 45 | 0 |
| K833457 | ETHYLENE OXIDE GAS STERILIZA SYS II | Ben Venue Laboratories, Inc. | 1983-12-29 | 85 | 0 |
| K834168 | FIBRINOGEN UPTAKE SYS -VARIOUS MODELS | Canberra Industries, Inc. | 1983-12-29 | 55 | 0 |
| K833714 | RESPIRATORY ASSESSMENT SYSTEM | Thoratec Laboratories Corp. | 1983-12-29 | 69 | 0 |
| K833704 | AMER. V. MUELLER SURGICALSTAPLES-CARTR | American Heyer Schulte | 1983-12-29 | 72 | 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