Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Alpha-Tec Systems, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
66 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K053257 | PARA-PRO FC50 | Alpha-Tec Systems, Inc. | 2006-05-12 | 171 | 0 |
| K890861 | ATS DOBELL & O'CONNOR'S IODINE | Alpha-Tec Systems, Inc. | 1989-03-23 | 30 | 0 |
| K890020 | ATS LUGOL'S IODINE SOLUTION | Alpha-Tec Systems, Inc. | 1989-02-24 | 51 | 0 |
| K890148 | ATS TB RAPID STAIN SET PRODUCT #034-45 | Alpha-Tec Systems, Inc. | 1989-01-24 | 11 | 0 |
| K890022 | ATS MAYER'S ALBUMIN | Alpha-Tec Systems, Inc. | 1989-01-10 | 6 | 0 |
| K883048 | ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION | Alpha-Tec Systems, Inc. | 1988-08-17 | 32 | 0 |
| K883049 | ATS PARA-SET IODINE ALCOHOL SOLUTION | Alpha-Tec Systems, Inc. | 1988-08-17 | 29 | 0 |
| K883062 | ATS SCHAUDINN'S FIXATIVE W/ACETIC ACID | Alpha-Tec Systems, Inc. | 1988-08-04 | 16 | 0 |
| K881949 | ATS NAC-PAC SET | Alpha-Tec Systems, Inc. | 1988-05-25 | 15 | 0 |
| K880989 | ATS CRYPTOSPORIDIUM STAIN SET | Alpha-Tec Systems, Inc. | 1988-05-13 | 66 | 0 |
| K881698 | ATS PVA FIXATIVE SOLUTION | Alpha-Tec Systems, Inc. | 1988-05-13 | 24 | 0 |
| K881879 | ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 | Alpha-Tec Systems, Inc. | 1988-05-13 | 9 | 0 |
| K880962 | ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES | Alpha-Tec Systems, Inc. | 1988-03-30 | 22 | 0 |
| K881042 | ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION) | Alpha-Tec Systems, Inc. | 1988-03-30 | 19 | 0 |
| K880990 | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION | Alpha-Tec Systems, Inc. | 1988-03-24 | 16 | 0 |
| K823706 | ATS AFB STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 | 29 | 0 |
| K823704 | ATS GRAM STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 | 29 | 0 |
| K823705 | ATS PARASITOLOGY STAIN CONTROL SLIDE | Alpha-Tec Systems, Inc. | 1983-01-07 | 29 | 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