Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Surgipath Medical Industries, Inc. · Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
20 daysmedian FDA review time
53 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883217 | SCHIFF REAGENT | Surgipath Medical Industries, Inc. | 1988-08-05 | 7 | 0 |
| K881921 | C-E BRUSH | Surgipath Medical Industries, Inc. | 1988-07-19 | 71 | 0 |
| K881922 | CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE | Surgipath Medical Industries, Inc. | 1988-05-25 | 16 | 0 |
| K881659 | TISSUE SECTION ADHESIVE | Surgipath Medical Industries, Inc. | 1988-04-21 | 6 | 0 |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Surgipath Medical Industries, Inc. | 1986-09-30 | 18 | 0 |
| K863616 | KNIFE MAKER | Surgipath Medical Industries, Inc. | 1986-09-25 | 9 | 0 |
| K863548 | ROTARY MICROTOME | Surgipath Medical Industries, Inc. | 1986-09-19 | 7 | 0 |
| K863483 | CASSETTE EMBOSSEER | Surgipath Medical Industries, Inc. | 1986-09-16 | 7 | 0 |
| K863145 | CERVICAL SCRAPERS | Surgipath Medical Industries, Inc. | 1986-08-19 | 4 | 0 |
| K861201 | FORMALDEHYDE SOLUTION, 37% | Surgipath Medical Industries, Inc. | 1986-04-11 | 11 | 0 |
| K861270 | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | Surgipath Medical Industries, Inc. | 1986-04-11 | 7 | 0 |
| K855109 | CLEARENE, CLEARING AGENT | Surgipath Medical Industries, Inc. | 1986-01-07 | 15 | 0 |
| K853497 | PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN | Surgipath Medical Industries, Inc. | 1985-08-28 | 8 | 0 |
| K852045 | SED-FIX CONCENTRATE | Surgipath Medical Industries, Inc. | 1985-06-10 | 32 | 0 |
| K850916 | SPRAYFIX | Surgipath Medical Industries, Inc. | 1985-03-25 | 20 | 0 |
| K850676 | SURGI-PAP KIT | Surgipath Medical Industries, Inc. | 1985-03-22 | 29 | 0 |
| K844640 | POLYSTAT, BIOLOGICAL STAIN | Surgipath Medical Industries, Inc. | 1985-01-30 | 63 | 0 |
| K841488 | DECALCIFIER I | Surgipath Medical Industries, Inc. | 1984-05-02 | 22 | 0 |
| K831580 | PARAFFIN INFILTRATION MEDIUM | Surgipath Medical Industries, Inc. | 1983-06-17 | 31 | 0 |
| K831333 | EMBEDDING RINGS | Surgipath Medical Industries, Inc. | 1983-05-25 | 30 | 0 |
| K831334 | TISSUE CASSETTES FOR PROCESSING-EM BED | Surgipath Medical Industries, Inc. | 1983-05-25 | 30 | 0 |
| K831308 | DISPOSABLE MICROTOME BLADE | Surgipath Medical Industries, Inc. | 1983-05-16 | 24 | 0 |
| K831335 | DISPOSABLE BASE MOLD | Surgipath Medical Industries, Inc. | 1983-05-16 | 21 | 0 |
| K830515 | SCOTTS TAP WATER SUBSTITUTE CONCENTRATE | Surgipath Medical Industries, Inc. | 1983-03-31 | 42 | 0 |
| K830582 | MILLONIG'S MODIFIED PHOSPHATE BUFFERED | Surgipath Medical Industries, Inc. | 1983-03-17 | 22 | 0 |
| K830583 | NEUTRAL BUFFERED FORMALIN 10% | Surgipath Medical Industries, Inc. | 1983-03-17 | 22 | 0 |
| K830659 | CLEARIUM, MOUNTING MEDIUM | Surgipath Medical Industries, Inc. | 1983-03-17 | 15 | 0 |
| K830514 | MILLONIGS MODIFIED PHOSPHATE BUFFERED | Surgipath Medical Industries, Inc. | 1983-03-08 | 19 | 0 |
| K810568 | PARAFFIN EMBEDDING MEDIUM | Surgipath Medical Industries, Inc. | 1981-03-17 | 14 | 0 |
| K770592 | CYTOLOGY FIXATIVE | Surgipath Medical Industries, Inc. | 1977-05-20 | 53 | 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