Techno-Path Manufacturing , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Techno-Path Manufacturing , Ltd.” (first 2013, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 5 | 74 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 203 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 496 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Techno-Path Manufacturing , Ltd. took a median 350 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 5 |
| DIF | Drug Mixture Control Materials | 1 | 1 |
| QCH | Assayed Quality Control Material For Clinical Microbiology Assays | 1 | 1 |
Review panels
Most recent Techno-Path Manufacturing , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) | QCH | 2025-12-30 | 496 |
| K162530 | Multichem IA Plus | JJY | 2017-03-31 | 203 |
| K132751 | MULTICHEM S PLUS / S PLUS (ASSAYED) | JJY | 2013-10-22 | 49 |
| K131993 | MULTICHEM U | JJY | 2013-10-15 | 109 |
| K131992 | MULTICHEM P | JJY | 2013-09-25 | 89 |
| K132174 | MULTICHEM WBT | DIF | 2013-09-20 | 67 |
| K132091 | MULTICHEM IA AND IA PLUS | JJY | 2013-09-20 | 74 |
Recalls
5 product recalls in 2 recall events; 5 initiated in the last five years. Most recent: 2025-10-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Techno-Path Manufacturing , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Techno-Path Manufacturing , Ltd.” (first 2013, latest 2025), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Techno-Path Manufacturing , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Techno-Path Manufacturing , Ltd. is 89 days.
Which FDA product codes appear under Techno-Path Manufacturing , Ltd.?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 5); DIF (Drug Mixture Control Materials, 1); QCH (Assayed Quality Control Material For Clinical Microbiology Assays, 1).
Next steps
- See all 7 Techno-Path Manufacturing , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JJY, Techno-Path Manufacturing , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.