Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shaban Mfg. Co. — Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
85 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853621 | REPLACEMENT PUMP TUBING | Shaban Mfg. Co. | 1985-12-05 | 98 | 0 |
| K850157 | CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS | Shaban Mfg. Co. | 1985-02-27 | 43 | 0 |
| K850333 | PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS | Shaban Mfg. Co. | 1985-02-27 | 30 | 0 |
| K844781 | MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB | Shaban Mfg. Co. | 1985-02-01 | 53 | 0 |
| K844235 | CHLORIDE STANDARD | Shaban Mfg. Co. | 1984-11-20 | 19 | 0 |
| K842656 | REPLACEMENT PARTS NOVA ELECTROLYTE ANAL | Shaban Mfg. Co. | 1984-08-12 | 33 | 0 |
| K841609 | COMPONENTS FOR PARTIAL PRESSURE ELEE | Shaban Mfg. Co. | 1984-05-25 | 46 | 0 |
| K841610 | COMPONENTS FOR POTASSIUM, SODIUM CHLO | Shaban Mfg. Co. | 1984-05-25 | 46 | 0 |
| K840557 | REAGENTS & STANDARDS IL 501 NA/K | Shaban Mfg. Co. | 1984-04-04 | 56 | 0 |
| K840468 | PARTIAL PRESS. ELECTRODE MEASUREMENT | Shaban Mfg. Co. | 1984-03-30 | 56 | 0 |
| K840530 | SUPPLIES FOR INSTRUMENTATION LAB FLAME | Shaban Mfg. Co. | 1984-03-30 | 65 | 0 |
| K833804 | SHABAN 9865 IL#78637 JUNCTION BLOC | Shaban Mfg. Co. | 1984-01-13 | 73 | 0 |
| K833693 | TEE ADAPTER 9890-FLUSH WINDING 282 | Shaban Mfg. Co. | 1983-12-30 | 73 | 0 |
| K833535 | POTASSIUM SODIUM ANALYSIS PRODUCTS | Shaban Mfg. Co. | 1983-12-29 | 93 | 0 |
| K833536 | PARTIAL PRESSURE ELECTRODE MEASUREMENT | Shaban Mfg. Co. | 1983-12-29 | 85 | 0 |
| K833534 | PARTIAL PRESSURE ELECTRODE MEASUREMENT | Shaban Mfg. Co. | 1983-12-29 | 93 | 0 |
| K832937 | SHABAN #9868 TUBING KIT-9870 STYLET | Shaban Mfg. Co. | 1983-10-14 | 45 | 0 |
| K832932 | SHABAN #9858 ASPIRATOR ASSEMBLE #9862- | Shaban Mfg. Co. | 1983-10-14 | 45 | 0 |
| K832931 | SHABAN #9852 CHIMNEY-#9854 SCREEN & | Shaban Mfg. Co. | 1983-10-14 | 45 | 0 |
| K832936 | SHABAN #9850 PUMP WINDINGS-9860 FILTER | Shaban Mfg. Co. | 1983-10-14 | 45 | 0 |
| K832584 | TUBING KIT 446 | Shaban Mfg. Co. | 1983-09-12 | 41 | 0 |
| K832415 | DEPROTEINIZING & CLEANING SOLUTION | Shaban Mfg. Co. | 1983-09-12 | 53 | 0 |
| K830588 | POTASSIUM ANALYZER-SODIUM/ELECTROLYTE | Shaban Mfg. Co. | 1983-04-27 | 63 | 0 |
| K830589 | ELECTROLYTE STANDARD - CORNING NALK ISE | Shaban Mfg. Co. | 1983-04-27 | 63 | 0 |
| K830636 | POTASSIUM DILUENT | Shaban Mfg. Co. | 1983-04-05 | 35 | 0 |
| K830341 | SALT BRIDGE SOLUTION & URINE DILUENT | Shaban Mfg. Co. | 1983-03-10 | 36 | 0 |
| K830283 | LITHIUM DILUENT | Shaban Mfg. Co. | 1983-02-28 | 33 | 0 |
| K823535 | DILUENT, ZEROING SOLUTION & CO-OX/ISE | Shaban Mfg. Co. | 1983-01-28 | 59 | 0 |
| K823750 | CLEANING AGENT | Shaban Mfg. Co. | 1983-01-14 | 31 | 0 |
| K821794 | NOVA V FLUIDS PACK & EXTERNAL STANDARDS | Shaban Mfg. Co. | 1982-07-02 | 14 | 0 |
| K821623 | NOVA IV FLUIDS PACK & EXTERNAL STANDARDS | Shaban Mfg. Co. | 1982-06-14 | 12 | 0 |
| K821030 | NOVA II FLUIDS PACK | Shaban Mfg. Co. | 1982-05-03 | 20 | 0 |
| K820947 | NOVA III FLUIDS PACK | Shaban Mfg. Co. | 1982-04-26 | 20 | 0 |
| K820701 | NOVA I FLUIDS PACK | Shaban Mfg. Co. | 1982-04-01 | 17 | 0 |
| K820700 | EXTERNAL STANDARDS-SODIUMNPOTASSIUM | Shaban Mfg. Co. | 1982-04-01 | 17 | 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