Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HTC — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
28 daysmedian FDA review time
50 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872384 | SIDE CUTTING PARALLEL ACTION PLIERS | Med-Tool, Inc. | 1987-07-02 | 13 | 0 |
| K864019 | NEEDLE NOSE PLIERS | Med-Tool, Inc. | 1986-10-30 | 15 | 0 |
| K861953 | PARALLEL ACTION PLIERS | Med-Tool, Inc. | 1986-06-06 | 17 | 0 |
| K854390 | WIRE CUTTING PLIERS OR LINEMAN'S PLIERS | Med-Tool, Inc. | 1985-11-19 | 19 | 0 |
| K844600 | SLIP JOINT PLIERS | Med-Tool, Inc. | 1984-12-14 | 17 | 0 |
| K844146 | TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW | Med-Tool, Inc. | 1984-11-20 | 28 | 0 |
| K840979 | SLIP JOINT PLIER | Med-Tool, Inc. | 1984-04-25 | 50 | 0 |
| K840980 | HALF ROUND FILE | Med-Tool, Inc. | 1984-04-25 | 50 | 0 |
| K840978 | TOGGLE LOCKING PLIER | Med-Tool, Inc. | 1984-04-25 | 50 | 0 |
| K830721 | WIRE TWISTERS | The Anspach Effort, Inc. | 1983-04-12 | 35 | 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