Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Newtech Development, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
172 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | International Newtech Development, Inc. | 2000-01-03 | 52 | 2 |
| K974060 | MINISTRIP/ SERUM AND URINE COMBO HCG TEST | International Newtech Development, Inc. | 1998-04-09 | 164 | 0 |
| K974059 | ONE STEP MIDSTREAM HCG PREGNANCY TEST | International Newtech Development, Inc. | 1998-04-09 | 164 | 3 |
| K974009 | PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG | International Newtech Development, Inc. | 1998-03-13 | 143 | 0 |
| K970176 | HCG CONTROLS | International Newtech Development, Inc. | 1997-02-06 | 20 | 0 |
| K963132 | MINI STRIP/SERUM HCG | International Newtech Development, Inc. | 1996-11-18 | 98 | 3 |
| K963133 | PS-UNIT CASSETTE/SERUM HCG | International Newtech Development, Inc. | 1996-11-18 | 98 | 1 |
| K951705 | MINISTRIP HCG | International Newtech Development, Inc. | 1995-10-03 | 172 | 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