Lamicel (R) Osmostic Cervical Dilator

P820075/S007PMAApproved Jan 3, 1996226-day reviewClass III

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

Medtronic Xomed, Inc. · LOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

Approved on Jan 3, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 226-day review.

Decided: Jan 3, 1996
Review: 226 days
Class: Class III
Product code: LOB
Recalls: None

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

FIG. 1 — Lineage of P820075/S007Source: FDA PMA database · How lineage is built

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

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

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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Does it have a predicate?

PMA decisions do not claim a predicate device.

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.

How does its category compare?

All LOB devices

LOB Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LOB

FDA has decided no LOB device since 2007.

Median 510(k) review, days · LOB

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

Recalls per year · LOB

3in 2019

2007high 3 (2019) · low 0 (2007)2026

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

Adverse event reports per year · LOB

2in 2013

2007high 2 (2013) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	2
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	3	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

https://510kreport.com/device/P820075/S007 · printed Nov 6, 2026

Cite this page

510(k) Report. “P820075/S007: Lamicel (R) Osmostic Cervical Dilator.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P820075/S007

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026