Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spintech, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
143 daysmedian FDA review time
323 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223079 | Stage | Spintech, Inc. | 2022-10-28 | 28 | 0 |
| K210843 | STAGE | Spintech, Inc. | 2021-06-29 | 99 | 0 |
| K173224 | SPIN-SWI | Spintech, Inc. | 2018-02-23 | 143 | 0 |
| K023722 | SAFETYWAND DISPOSABLE HANDPIECE | Spintech, Inc. | 2003-09-02 | 301 | 0 |
| K010692 | THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM | Spintech, Inc. | 2001-06-29 | 113 | 0 |
| K992404 | THE WAND | Spintech, Inc. | 2000-06-06 | 323 | 0 |
| K992819 | WAND PLUS | Spintech, Inc. | 2000-05-11 | 265 | 0 |
| K961648 | THE WAND | Spintech, Inc. | 1996-07-05 | 67 | 0 |
| K955654 | SHORTSTOP DISPOSABLE PROPHY ANGLE | Spintech, Inc. | 1996-02-08 | 58 | 0 |
| K922238 | LEAPLAZA FRAME | Spintech, Inc. | 1992-12-23 | 224 | 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