510(k) Report

510(k) · Cleared

Cleared

Iob Disposable Speculum

K132668510(k) TraditionalCleared Jan 17, 2014143-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

Iob Medical, Inc. · HIB Speculum, Vaginal, Nonmetal

Cleared on Jan 17, 2014 as substantially equivalent to K091937 (Obp Corporation, 2009) after a 143-day review. Its family tree reaches back 1 generation to 2009.

Decided
Jan 17, 2014
Review
143 days
Class
Class II
Product code
HIB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K091937 (2009). No later device cites it as a predicate yet.

K091937 · Office-Spec Disposable Side-Opening Speculum · Obp Corporation · 2009 · recalled200620082010201220142016
K091937 · Office-Spec Disposable Side-Opening Speculum · Obp Corporation · 2009 · recalled0
  1. Root · 1 generation backK091937 Office-Spec Disposable Side-Opening SpeculumObp Corporation · 2009 · Recalled
  2. This deviceK132668 Iob Disposable SpeculumIob Medical, Inc. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K091937Office-Spec Disposable Side-Opening SpeculumObp Corporation20091
0 (this device)K132668Iob Disposable SpeculumIob Medical, Inc.2014—
FIG. 1 — Lineage of K132668, 2009–2014Source: 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
*K091937Office-Spec Disposable Side-Opening Speculum
Summary page 1
…21CFR 884-4530 Speculumn Vaginal nonmetal OB1STRETICS AND GYNECOLOGY 6. Predicate Devices: K09 1937 OBP Office-Spec Disposable Side Speculum 7. Intended Use The lOB Disposable Speculum is used to dilate the vagina and ex…
Obp Corporation20091

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 a recall.

How does its category compare?

All HIB devices

HIB Speculum, Vaginal, Nonmetal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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 108 Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.

Indications for use as stated in the FDA summary.

More from Iob Medical, Inc.

7 FDA decisions under this applicant name. See the company

  • K232638FilteredFlo Warming BlanketsIob Medical, Inc. · 2023
  • K231596IOB Temperature Management SystemIob Medical, Inc. · 2023
  • K221669IOB Warming BlanketsIob Medical, Inc. · 2022
  • K201896ivi N3003 Surgical face Mask, ivi N6006 Surgical maskIob Medical, Inc. · 2021
  • K190221IOB Warming BlanketsIob Medical, Inc. · 2019

Recent decisions in HIB

The HIB category page

  • K252208JFord Speculum Sleeve™Ford Medtech, LLC · 2026
  • K133857Brella-Spec (TM) Vaginal SpeculumProa Medical, Inc. · 2014
  • K130046Clearspec Single Use Vaginal SpeculumClearspec, LLC · 2013
  • K120743Speculum, Vaginal, NonmetalWelch Allyn, Inc. · 20121 recall
  • K110766Kolplux SystemKolplast CI Ltda · 2011

https://510kreport.com/device/K132668 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132668: Iob Disposable Speculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132668

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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