510(k) Report

FDA applicant

Ssl Americas, Inc.

Norcross, GA15 decisions2002–20084 recalls

FDA records 15 decisions for Ssl Americas, Inc. (Norcross, GA) from 2002 to 2008: 15 510(k) clearances. Most are in product codes HIS (Condom) and NUC (Lubricant, Personal). Its devices cite 40 predicates, 9 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Ssl Americas”.

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 Ssl Americas, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2008

2008: 4
2007high 4 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2018

2018: 4
2007high 4 (2018) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ssl Americas, Inc.’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

Which product codes does it file in?

  • HISCondom7decisions
  • NUCLubricant, Personal5decisions
  • KMJLubricant, Patient1decision
  • MOLCondom, Synthetic1decision
  • DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)1decision

Whose devices does it build on?

Its devices cite 40 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 9 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.

  • K032124Durex Play LubricantSsl Americas, Inc. · 20047cite it
  • K042563Durex Play Warmer LubricantSsl Americas, Inc. · 20053cite it
  • K060098Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 20063cite it
  • K040353Flight SockSsl Americas, Inc. · 20042cite it
  • K020659Durex Latex Condom with Male Genital Desensitizer LubricantSsl Americas, Inc. · 20021cites it
  • K040185Durex Studded/Ribbed Lubricated Latex CondomSsl Americas · 20041cites it

What has FDA decided for it lately?

  • K072169Durex Synthetic Polyisoprene Male CondomSsl Americas, Inc. · 20084 recalls
  • K072236Durex Play Tingling Aqueous Based LubricantSsl Americas · 2008
  • K071626Durex Play Soft & Sensual LubricantSsl Americas · 2008
  • K063385Durex Play Massage Gel LubricantSsl Americas, Inc. · 2008
  • K060098Durex Play Temptations Assorted LubricantsSsl Americas, Inc. · 2006
  • K052959Durex Male Colored Latex Condoms with Scented LubricantsSsl Americas · 2006
  • K042958Durex Play Tingling LubricantSsl Americas, Inc. · 2005
  • K042470Durex Spearmint Scented Lubricated Latex Condom (Durex 'Tingling Pleasure' CondomSsl Americas, Inc. · 2005

All 10 as Ssl Americas, Inc. →All 5 as Ssl Americas →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K072169Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00…Dec 19, 2018Class II
  • K072169Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00…Dec 19, 2018Class II
  • K072169Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is…Aug 6, 2018Class II
  • K072169Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14…Jul 23, 2018Class II