510(k) Report

510(k) · Cleared

Cleared

Hierspec Speculum

K061339510(k) TraditionalCleared Sep 19, 2006127-day reviewClass II21 CFR 884.4530

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Products Div. · HIB Speculum, Vaginal, Nonmetal

Cleared on Sep 19, 2006 as substantially equivalent to K941272 (Welch Allyn, Inc., 1994) after a 127-day review. Its family tree reaches back 1 generation to 1994.

Decided
Sep 19, 2006
Review
127 days
Class
Class II
Product code
HIB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K941272 (1994). No later device cites it as a predicate yet.

K941272 · Kleenspec · Welch Allyn, Inc. · 19941990199520002005
K941272 · Kleenspec · Welch Allyn, Inc. · 19940
  1. Root · 1 generation backK941272 KleenspecWelch Allyn, Inc. · 1994
  2. This deviceK061339 Hierspec SpeculumMedical Products Div. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941272KleenspecWelch Allyn, Inc.1994—
0 (this device)K061339Hierspec SpeculumMedical Products Div.2006—
FIG. 1 — Lineage of K061339, 1994–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HIB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HIB device

  1. #1 K252208 JFord Speculum Sleeve™score 11.9 · 4 generations · no Class I recall
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K941272Kleenspec
Summary page 1
…884.4530 Product Code: Hil Predicate Device Device Name: Kleenspec Manufacturer: Welch Allyn 510(k) Number K94 1272 Indications For Use The Hier-Spec vaginal speculum is a non-metal (Acrylic and Polycarbona…
Welch Allyn, Inc.1994—

Also cleared against K941272: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 2 other devices also cite its predicate K941272.

How does its category compare?

All HIB devices

HIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIB

2in 2014

2007: 12008: 22009: 12010: 12011: 12012: 12013: 12014: 22026 (partial year): 1
2007high 2 (2008) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HIB

Too few HIB 510(k)s in any year since 2007 to give a median.

Recalls per year · HIB

1in 2015

2015: 12026 (partial year): 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HIB

3in 2025

2007: 12008: 22009: 12010: 102011: 152012: 152013: 92014: 82015: 52016: 22017: 52018: 32019: 42020: 42021: 42022: 22023: 32024: 22025: 3
2007high 15 (2011) · low 1 (2007)2025

MAUDE reports naming product code HIB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—01
20082—02
20091—01
20101—010
20111—015
20121—015
20131—09
20142—08
20150—15
20160—02
20170—05
20180—03
20190—04
20200—04
20210—04
20220—02
20230—03
20240—02
20250—03
20261—1—

What is it indicated for?

The Hier-Spec vaginal speculum is a non-metal (Acrylic and Polycarbonate), hand held device used to open the vagina and provide access to the cervix for gynecological or obstetrical examinations and procedures.

Indications for use as stated in the FDA summary.

Also cleared against K941272

2 other devices cite the same predicate.

  • K070964Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination SystemWelch Allyn, Inc. · 2007
  • K991827Ginram Specuvag, Ginram Specuvag as, Ginram Cuscovag, Models 720101, 720102, 720103, 720179, 720227, 720043Ri Mos. S.R.L. · 1999

Recent decisions in HIB

The HIB category page

  • K252208JFord Speculum Sleeve™Ford Medtech, LLC · 2026
  • K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014
  • K132668Iob Disposable SpeculumIob Medical, Inc. · 2014
  • K130046Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
  • K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 20121 recall

https://510kreport.com/device/K061339 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061339: Hierspec Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061339

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026