Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Threshold Industries, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
203 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | American Threshold Industries, Inc. | 1997-06-24 | 62 | 0 |
| K953879 | SURGEON'S CAP | American Threshold Industries, Inc. | 1996-01-05 | 142 | 0 |
| K953878 | BOUFFANT CAP | American Threshold Industries, Inc. | 1996-01-05 | 142 | 0 |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | American Threshold Industries, Inc. | 1995-09-25 | 143 | 0 |
| K952114 | KOOL GARD SINGLES GOWN | American Threshold Industries, Inc. | 1995-09-25 | 143 | 0 |
| K952116 | COVER GOWN | American Threshold Industries, Inc. | 1995-09-05 | 123 | 0 |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | American Threshold Industries, Inc. | 1993-11-12 | 84 | 0 |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | American Threshold Industries, Inc. | 1992-08-17 | 251 | 0 |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | American Threshold Industries, Inc. | 1992-06-22 | 182 | 0 |
| K912110 | DISPOSABLE O.R. TOWEL | American Threshold Industries, Inc. | 1991-07-25 | 73 | 0 |
| K894383 | DISPOSABLE SHOE COVER | American Threshold Industries, Inc. | 1989-09-12 | 57 | 0 |
| K851823 | DISPOSABLE ISOLATION GOWN | American Threshold Industries, Inc. | 1985-05-17 | 21 | 0 |
| K832486 | PILLOW COVER, ANTI-MICROBIAL | American Threshold Industries, Inc. | 1984-02-13 | 203 | 0 |
| K832487 | DRAW SHEET, ANTI-MICROBIAL | American Threshold Industries, Inc. | 1984-02-13 | 203 | 0 |
| K832483 | MATTRESS COVER, ANTI-MICROBIAL | American Threshold Industries, Inc. | 1984-02-04 | 194 | 0 |
| K830473 | NOVA GAUZE | American Threshold Industries, Inc. | 1983-04-15 | 59 | 0 |
| K831062 | ISOLATION MASK I.C.S. | American Threshold Industries, Inc. | 1983-04-13 | 5 | 0 |
| K822484 | INFECTION CONTROL TOWEL | American Threshold Industries, Inc. | 1982-09-30 | 44 | 0 |
| K810646 | OR/CS WRAP | American Threshold Industries, Inc. | 1981-03-20 | 10 | 0 |
| K801036 | SURGICAL MASK | American Threshold Industries, Inc. | 1980-06-04 | 33 | 1 |
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