FDA applicant

Line One Laboratories

Los Angeles, CA6 decisions1997–20100 recalls

FDA records 6 decisions for Line One Laboratories (Los Angeles, CA) from 1997 to 2010: 6 510(k) clearances. Most are in product codes HIS (Condom) and MSC (Barrier, Std, Oral Sex). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Line One Laboratories, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Line One Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Line One Laboratories by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Line One Laboratories’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Line”

FDA records each applicant name separately; these may or may not be the same firm.

Line One Laboratories & Trading Co. 3 Line Ind.(Shanghai) Co., Ltd. 1 Line Imaging Systems 1

Line One Laboratories

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Line”