510(k) Report

FDA applicant

Albaad Fem

Caesarea Ind. Park, IL3 decisions2018–20190 recalls

FDA records 3 decisions for Albaad Fem (Caesarea Ind. Park, IL) from 2018 to 2019: 3 510(k) clearances. All are in product code HEB (Tampon, Menstrual, Unscented). Since 2016 its 510(k)s took a median of 131 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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 Albaad Fem’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 22019: 1
2018high 2 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Albaad Fem by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • HEBTampon, Menstrual, Unscented3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 131 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 140 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem · 20182cite it

What has FDA decided for it lately?

  • K191431Interlude Rolled Tampons in Plastic ApplicatorAlbaad Fem · 2019
  • K181911Interlude 100% Cotton TamponAlbaad Fem · 2018
  • K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem · 2018

All 3 as Albaad Fem →

Other applicant names beginning “Albaad”

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

Albaad, Ltd. 1