Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Volu Sol Medical Industries · Predicate Candidate Screening

66 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

17 daysmedian FDA review time
106 days90th percentile
66clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K822129VOLU-SOL BOVINS FIXATIVEVolu Sol Medical Industries1982-08-05170
K822128VOLU-SOL SINGLE DIFFERENTIAL STAINVolu Sol Medical Industries1982-08-05170
K822127VOLU-SOL ZENKERS FIXATIVEVolu Sol Medical Industries1982-08-05170
K822126VOLU-SOL CARNOY FLUIDVolu Sol Medical Industries1982-08-05170
K822037VOLU-SOL TAP WATER SUBSTITUTEVolu Sol Medical Industries1982-08-03220
K822038VOLU-SOL ORANGE G-6(GILLS-MODVolu Sol Medical Industries1982-08-03220
K822035VOLU-SOL GILLS EAVolu Sol Medical Industries1982-08-03220
K822036VOLU-SOL DECALCIFERVolu Sol Medical Industries1982-08-03220
K812906ELVI BICLOT 816Volu Sol Medical Industries1982-07-222760
K821533HEMATOXYLIN IVolu Sol Medical Industries1982-06-10200
K821540HEMATOXYLIN IIVolu Sol Medical Industries1982-06-10170
K821541HEMATOXYLIN IIIVolu Sol Medical Industries1982-06-10170
K820634TRICHROME STAINVolu Sol Medical Industries1982-03-26180
K812121DIGICLOT 2-#820Volu Sol Medical Industries1981-11-161120
K812122MULTI CLOT-#819Volu Sol Medical Industries1981-11-101060
K810261EUROCHIMA UREA NITROGENVolu Sol Medical Industries1981-02-10110
K801143VOLU-SOL URINARY DICHROME STAINVolu Sol Medical Industries1980-05-30120
K800942VOLU-SOL EOSIN Y STAINVolu Sol Medical Industries1980-05-08160
K800325VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65Volu Sol Medical Industries1980-02-26140
K800322VOLU-SOL EA-50 STAINVolu Sol Medical Industries1980-02-26140
K800323VOLU-SOL ORANGE G-6 STAINVolu Sol Medical Industries1980-02-22100
K800324VOLU-SOL HARRIS HEMATOXYLINVolu Sol Medical Industries1980-02-22100
K792554ELVI MUCAPROTEINSVolu Sol Medical Industries1980-01-16370
K792555ELVI NON-ESTERIFIED FATTY ACIDSVolu Sol Medical Industries1980-01-16370
K792407ELVI-AMINOLEVULINIC ACIDVolu Sol Medical Industries1980-01-16510
K791458AGGLUTINOTEST-THYROGLOBULINVolu Sol Medical Industries1979-12-311470
K791455AGGLUTINOTEST-INFECTIOUS MONONUCLEOSISVolu Sol Medical Industries1979-12-311470
K791461AGGLUTINOTEST-C-REACTIVE PROTEINVolu Sol Medical Industries1979-12-311470
K792496VOLU-SOL NMB RETICULOCYTE STAINVolu Sol Medical Industries1979-12-31270
K791507AGGLUTINOTEST-RHEUMATOID ARTHRITISVolu Sol Medical Industries1979-12-311520
K792495VOLU-SOL URINARY SEDIMENT STAINVolu Sol Medical Industries1979-12-18140
K792497VOLU-SOL STATIM STAINVolu Sol Medical Industries1979-12-18140
K792402ELVI CREATININVolu Sol Medical Industries1979-12-07110
K792405ELVI ACID & PROSTATIC PHOSPHATASEVolu Sol Medical Industries1979-12-07110
K792398ELVI GLUCOSEVolu Sol Medical Industries1979-12-07110
K792415ELVI TOTAL BILIRUBIN & FRACTIONSVolu Sol Medical Industries1979-12-07110
K792404ELVI CREATININEVolu Sol Medical Industries1979-12-07110
K792414ELVI TRIGLYCERIDEVolu Sol Medical Industries1979-12-07110
K792400ELVI CHLORIDEVolu Sol Medical Industries1979-12-07110
K792416ELVI TOTAL PROTEINSVolu Sol Medical Industries1979-12-07110
K792401ELVI INORGANIC PHOSPHOROUSVolu Sol Medical Industries1979-12-07110
K792399ELVI MAGNESIUMVolu Sol Medical Industries1979-12-07110
K792412ELVI URIC ACIDVolu Sol Medical Industries1979-12-07110
K792417ELVI BLOOD UREA NITROGENVolu Sol Medical Industries1979-12-07110
K792406ELVI SERUM IRONVolu Sol Medical Industries1979-12-07110
K792397ELVI CREATININEVolu Sol Medical Industries1979-12-07110
K792413ELVI ALKALINE PHOSPHATATASEVolu Sol Medical Industries1979-12-07110
K792403ELVI URIC ACID-COLORIMETRIC METHODVolu Sol Medical Industries1979-12-07110
K792411ELVI TOTAL BILIRUBIN & FRACTIONSVolu Sol Medical Industries1979-12-06100
K792409ELVI TOTAL IRON BINDING CAPACITYVolu Sol Medical Industries1979-12-06100

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