Line One Laboratories: FDA filings under this applicant name
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Line One Laboratories” (first 1997, latest 2010), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 88 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 5 | 5 |
| MSC | Barrier, Std, Oral Sex | 1 | 1 |
Review panels
Most recent Line One Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091769 | TRUST DAM | MSC | 2010-02-05 | 234 |
| K991892 | TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR | HIS | 1999-08-19 | 77 |
| K970633 | TUSTEX FLAVORED CONDOMS | HIS | 1997-03-21 | 29 |
| K964599 | TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR | HIS | 1997-02-14 | 88 |
| K964598 | TRUSTEX COLA FLAVORD CONDOM | HIS | 1997-02-14 | 88 |
| K964591 | TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR | HIS | 1997-02-13 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Line One Laboratories.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Line One Laboratories (5)
- Line One Laboratories, Inc. (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Line One Laboratories & Trading Co. (3 510(k)s)
- Line Imaging Systems (1 510(k)s)
- Line Ind.(Shanghai) Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Line One Laboratories?
FDA lists 6 510(k) clearances under 2 spellings of the applicant name “Line One Laboratories” (first 1997, latest 2010), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Line One Laboratories?
The median time from FDA receipt to decision across 510(k)s cleared under the name Line One Laboratories is 88 days.
Which FDA product codes appear under Line One Laboratories?
The most frequent FDA product codes under this applicant name are HIS (Condom, 5); MSC (Barrier, Std, Oral Sex, 1).
Next steps
- See all 6 Line One Laboratories clearances with predicates and recalls
- Run predicate analysis for product code HIS, Line One Laboratories'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.