Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
V-Tech, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
208 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914303 | TARGET(TM)-HOG | V-Tech, Inc. | 1991-10-11 | 16 | 0 |
| K910892 | TARGET(TM) CANNABINOIDS-V TEST | V-Tech, Inc. | 1991-04-03 | 30 | 0 |
| K910893 | TARGET(TM) CANNABINOIDS-R TEST | V-Tech, Inc. | 1991-04-03 | 30 | 0 |
| K910739 | TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) | V-Tech, Inc. | 1991-03-21 | 28 | 0 |
| K910738 | TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) | V-Tech, Inc. | 1991-03-19 | 26 | 0 |
| K910122 | TARGET COCAINE METABOLITE-R | V-Tech, Inc. | 1991-03-19 | 67 | 0 |
| K910123 | TARGET COCAINE METABOLITE-V | V-Tech, Inc. | 1991-03-19 | 67 | 0 |
| K903937 | TARGET(TM) HOG ONE STEP | V-Tech, Inc. | 1990-10-22 | 56 | 0 |
| K890978 | TARGET OPIATES-R | V-Tech, Inc. | 1989-11-17 | 263 | 0 |
| K890979 | TARGET OPIATES-V | V-Tech, Inc. | 1989-10-04 | 219 | 0 |
| K890295 | TARGET(TM) CK-MB | V-Tech, Inc. | 1989-08-15 | 208 | 0 |
| K890131 | TARGET(TM) QUANTITATIVE HCG | V-Tech, Inc. | 1989-03-09 | 56 | 0 |
| K885254 | TARGET READER | V-Tech, Inc. | 1989-01-27 | 35 | 0 |
| K882588 | BLUE DOT(TM) TEST FOR PREGNANCY | V-Tech, Inc. | 1988-10-06 | 105 | 0 |
| K880460 | TARGET STREP A | V-Tech, Inc. | 1988-03-03 | 29 | 0 |
| K862247 | TARGET HCG, ENZYME IMMUNOASSAY REAGENTS | V-Tech, Inc. | 1986-07-29 | 47 | 0 |
| K861918 | V-TREND EIA TSH | V-Tech, Inc. | 1986-07-02 | 44 | 0 |
| K854971 | V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT | V-Tech, Inc. | 1986-02-06 | 57 | 0 |
| K854972 | V-TREND DIG ENZYME IMMUNOASSAY TEST KIT | V-Tech, Inc. | 1986-01-22 | 42 | 0 |
| K854973 | V-TREND OC CPK | V-Tech, Inc. | 1986-01-13 | 33 | 0 |
| K823363 | COUNT-10 STAIN | V-Tech, Inc. | 1982-12-15 | 36 | 0 |
| K823364 | COUNT-10 SYSTEM FOR STAND. URINALYSIS | V-Tech, Inc. | 1982-12-15 | 36 | 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