Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4220](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4220) → JDY — Evacuator, Vapor, Cement Monomer

# JDY · Evacuator, Vapor, Cement Monomer

_Orthopedic · 21 CFR 888.4220 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY

## Overview

- **Product Code:** JDY
- **Device Name:** Evacuator, Vapor, Cement Monomer
- **Regulation:** [21 CFR 888.4220](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4220)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (§ 888.3027).

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K902167](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY/K902167.md) | CONTAIN(TM) LASER PLUME FILTER | Arbor Technologies, Inc. | Jan 4, 1991 | SESE |
| [K902056](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY/K902056.md) | LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER | Hollister, Inc. | Oct 30, 1990 | SESE |
| [K862509](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY/K862509.md) | CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000 | Lifestream Int'L, Inc. | Jul 23, 1986 | SESE |
| [K810542](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY/K810542.md) | CEMENT FUME EVACUATOR TANK & FILTER | Walgen Medical Innoventions | Mar 13, 1981 | SESE |
| [K790877](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY/K790877.md) | BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO | Stackhouse Assoc. | May 23, 1979 | SESE |
| [K780202](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY/K780202.md) | MONOMER EVACUATION SYSTEM | Medishield, Inc. | Feb 21, 1978 | SESE |
| [K770690](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY/K770690.md) | MASK, VAPOR, MONOMER | Howmedica Corp. | Jul 21, 1977 | SESE |
| [K760906](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY/K760906.md) | MONOMER VAPOR CONTAINMENT SYSTEM | Howmedica Corp. | Nov 11, 1976 | SESE |

## Top Applicants

- Howmedica Corp. — 2 clearances
- Arbor Technologies, Inc. — 1 clearance
- Hollister, Inc. — 1 clearance
- Lifestream Int'L, Inc. — 1 clearance
- Medishield, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/JDY)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com