Cleared Traditional

K984211 - MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM

Also marketed or referenced as:
EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303

K984211 is an FDA 510(k) clearance for MEDSCAND DISPOSABLE PLASTIC VAGINAL SPE..., manufactured by Medscand AB. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K984211 · Medscand AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
29d
Days
Class 2
Risk

K984211 is an FDA 510(k) clearance for the MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Medscand AB (Malmo, SE). The FDA issued a Cleared decision on December 23, 1998 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medscand AB devices

FDA 510(k) Submission Details - K984211

510(k) Number K984211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date December 23, 1998
Days to Decision 29 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 160d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIB Speculum, Vaginal, Nonmetal

All 19
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K984211.
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · Cypress Medical Products, Ltd. · Jul 2002
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
K992736 · Wallach Surgical Devices, Inc. · Sep 1999
VITALCARE DISPOSABLE VAGINAL SPECULUM
K983716 · Vitalcare Group, Inc. · Dec 1998
KOLPLAST VAGINAL SPECULUM
K973853 · Kolplast Comercial E Industrial Ltda · Dec 1997
HOSPITAL'S SPEC
K974228 · Gps · Dec 1997
PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS
K971979 · Playtex Products, Inc. · Sep 1997